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Endoscopic retrograde cholangiopancreatography (ERCP) is the first-line therapy for choledocholithiasis and associated pancreaticobiliary pathology, with over half a million procedures annually in the United States alone.[[1]] Pancreaticobiliary pathology is more common in the elderly, with an estimated 10–20% of elderly patients presenting with cholecystitis having coexisting choledocholithiasis, compared to 5% in the general population. In addition, the incidence of ductal stones in elderly patients undergoing emergency cholecystectomy approaches 50%.[[2,3]] Due to an ageing worldwide population, ERCP is increasingly utilised in the elderly as a therapeutic tool.[[3–6]] Despite this, ERCP in the elderly is purported to be associated with increased procedural difficulty and periprocedural adverse events. The increased risk might be expected due to a higher prevalence of frailty and comorbidities in this population, and the safety of ERCP in the elderly is often debated, with age frequently cited as a contraindication.[[7]]

Despite the perceived risks of ERCP in the elderly, there are limited comparative studies on outcomes. Literature on the safety and complication rates of older patients undergoing ERCP is conflicting. A systematic review of 18 studies by Harmeet et al. in 2017 concluded that ERCP was safe in the elderly, with higher rates of post-ERCP pancreatitis reported in younger patients.[[2,7]] Another study of octogenarians undergoing ERCP with a mean age of 84 years cited a mortality rate of 3.1%, which is considerably lower than the standard quoted mortality rate of 5%.[[3,8]] In contrast, high rates of post-ERCP mortality were reported by Kalaitzakis et al. in the very elderly >80 years, mainly due to underlying diseases, notably cancer.[[8]] Sedation for ERCP is also associated with increased risks in the elderly and may contribute to periprocedural morbidity and mortality.[[9]]

To our knowledge, there is no comparative outcomes data for elderly patients undergoing ERCP in New Zealand. Increased understanding of the complication and outcomes of ERCP could help clinicians select the best therapeutic approach and potentially avoid exposing vulnerable patients to risky interventions.

Methods

The records of 509 consecutive ERCP procedures performed between September 2019 and September 2020 were retrospectively reviewed. Procedural details were captured from endoscopy reports via ProVation® MD software. In addition, a comprehensive assessment of clinical records, including radiology and laboratory data, was completed. Specific data collected included demographics, procedural indication, American Society for Gastrointestinal Endoscopy (ASGE) complexity score,[[10,11]] procedural techniques and whether non-steroidal anti-inflammatories (NSAIDs) were prescribed. Comorbidities were classified using the Charlson Comorbidity Index (CCI) below. The cause of death was obtained via clinical records. Patients were divided into elderly >75 years and controls ≤75 years old for analysis and comparison. Ethics approval was obtained from the Health and Disability Ethics Committee.

All procedures were completed by four consultant gastroenterologists and a senior endoscopy fellow at Middlemore Hospital. Middlemore Hospital is a tertiary referral centre for Counties Manukau District Health Board in Auckland, New Zealand and services approximately 567,000 people, representing 11% of the total New Zealand population in 2018.[[12]] Both emergency and elective ERCP were included. The majority utilised conscious sedation with a combination of midazolam and fentanyl as directed by the endoscopist. A small number of procedures were conducted with propofol or general anaesthesia. Rectal NSAIDs with diclofenac were prescribed at the start of each procedure for post-ERCP pancreatitis (PEP) prophylaxis at the endoscopist’s discretion. Cannulation was typically carried out using a guidewire-assisted technique with a sphincterotome; other interventions such as needle-knife or trans-pancreatic precut sphincterotomy, dilatation and stenting were carried out depending on the requirements of each procedure and the endoscopist expertise.

Charlson Comorbidity Index

CCI is an internationally recognised method of categorising comorbidities based on the International Classification of Diseases. Comorbidities are weighted based on the adjusted risk of mortality or resource use at one year, and the sum of all the weights results in a single comorbidity score for each patient.[[13,14]] Nineteen conditions are used in the scoring system and given a weight based on the estimated mortality hazard ratio from a Cox proportional hazards model. A score of zero indicates no comorbidities, whilst a score of five or more may be considered highly comorbid. Studies have shown that using the CCI as a composite score is a better predictor of prognosis than individual comorbidities alone.[[14]]

Primary and secondary outcomes

The primary outcome was complications from ERCP based on clinical records, laboratory findings and radiology results. Pancreatitis was classified using the revised Atlanta classification for pancreatitis, which requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis; (b) serum amylase or lipase level greater than three times the upper normal value; or (c) characteristic imaging findings.[[15]] In addition, the Cotton criteria were used for grading bleeding, perforation and sepsis.[[10,16]] We also examined variables that predicted PEP in a multivariate analysis model.

Secondary outcomes were the length of hospital stay after complications from ERCP, intensive care admissions, and all-cause mortality at 30 and 90 days following ERCP.

Statistics

Our sample size was greater than the estimated sample size of 400 procedures required to detect a 10% difference between study groups for combined adverse events from ERCP (α 0.05; statistical power 80%; 1:3 enrolment ratio).

Fisher’s exact test was used for categorical variables, and the Mann–Whitney U test for non-categorical variables was performed to compare study groups. Statistical significance was set at the p value <0.05 (two-sided) level. Potential variables for ERCP complications were entered into a multivariate logistic regression analysis with odds ratio adjusted for potential confounders. Mortality results were presented using Kaplan–Meier survival curves. Data analysis was completed using IBM Statistics 26 program (SPSS Inc, Chicago, III).

Results

A total of 509 ERCP procedures performed on 338 patients were included. The mean age was 61 years (range 16–93). The elderly >75 years cohort comprised 23% (117/509) of the total procedures. Compared to the younger cohort, the elderly were more likely to be male (53.8% vs 39.8%; p=0.007) and of NZ European ethnicity (51.3% vs 35.2%; p=0.002). The elderly cohort also had a significantly higher CCI (mean 6.25 vs 3.17). There was no significant difference in ERCP indications and ASGE complexity score between the elderly and young groups. The most common indication for ERCP was choledocholithiasis (43%), ascending cholangitis (16.3%), pancreatic cancer (9.4%), gallstone pancreatitis (6.9%), biliary cancer (5.5%) and jaundice—cause not specified (5.5%). The elderly group were less likely to receive NSAIDs at ERCP (9.4% vs 19.3%; p=0.002). Other procedural characteristics were similar between groups (Table 1).

Complications from ERCP

Forty-four complications occurred in 42 (8%) patients, 11 (2%) of which were severe, including four deaths. Pancreatitis occurred in six (5.1%) patients of the elderly versus 27 (6.9%) patients in the younger cohort, with no statistical difference (p=0.669). In addition, there was no difference in the total number of complications, intensive care admissions and length of hospital stay after complications (median four days in elderly vs five days in the younger cohort; p=0.354) (see Table 2). Complication rates did not differ between senior endoscopists or in cases involving a fellow.

Predictors of PEP

Multivariate logistical regression showed that neither age >75 years nor CCI ≥5 was associated with an increased risk of PEP. After adjusting for other variables, an increased risk of PEP was observed in females (adjusted odds ratio AOR=2.93; 95% confidence interval (CI):1.12–7.67; p=0.028), pre-cut sphincterotomy (AOR=6.82; 95% CI:1.82–25.6; p=0.004) and pancreatic sphincterotomy (AOR=23.65; 95% CI: 3.74–149.7; p=0.001). Interestingly, ASGE complexity score was not associated with an increased risk of PEP; however, NSAID use was associated with PEP (AOR=4.28; 95% CI: 1.89–9.7; p=0.001) (see Table 3).

30- and 90-day all-cause mortality

At 30-days post ERCP, there were 22 deaths from any cause, representing 4.32% of the study population. Fifty deaths (9.8%) were observed at 90 days post ERCP. All-cause mortality was significantly higher in the elderly group at 30 days (8.5% vs 2%; p=0.002) and 90-days (19.7% vs 6.9%; p<0.001). Causes of death at 90 days are summarised in Figure 1.

After adjusting for sex and ethnicity, multivariate logistical regression showed that a CCI ≥5 significantly increased all-cause mortality at 90 days (AOR=74.44; 95% CI: 9.78–566.38; p<0.001), followed by malignant biliary disease (AOR=2.89; 95% CI: 1.44–5.79; p=0.003) and age >75 years (AOR=2.28; 95% CI: 1.14–4.55; p=0.02). Complications from ERCP did not significantly increase the odds of death at 90-days in our model (see Table 4). Considering patients in both groups, CCI ≥5 increased the odds of death at 90 days (see Figure 2).

View Tables 1–4 & Figures 1–2.

Discussion

Our finding is the first of its kind in New Zealand and adds to the growing literature on ERCP in the elderly. There was no difference in ERCP complication rates between the elderly and younger patients. This is consistent with an earlier systematic review that demonstrated incidence rates of ERCP complications for elderly patients similar to most reported literature.[[17]] While several studies have established the safety and efficacy of ERCP in the elderly, they had limitations with lacking a comparator group or including outcomes for elderly patients as young as 60 years old.[[18–20]]

Counter-intuitively, NSAID use was associated with increased pancreatitis in multivariate analysis. At the time of this study, NSAID use was at the endoscopist’s discretion and typically only for patients considered at high risk of PEP. The overall NSAID use was significantly lower in the elderly cohort, and this should increase the risk of pancreatitis in the elderly, but our findings show similar rates of pancreatitis versus the younger cohort. Advancing age has been shown to have a protective role against the development of PEP in prior studies and, perhaps, offset the effects of lower NSAID use amongst the elderly.[[2]]

While ERCP-related mortality is well-described, there is a lack of comparative data on all-cause mortality in the elderly and few studies that incorporate a standardised comorbidity index. We reported a 9.8% all-cause mortality at 90 days post ERCP, comparable to published data from international registries.[[8,21,22]] Mortality post ERCP was driven primarily by comorbidities, and a CCI of ≥5 was the strongest predictor of death. 90-day mortality was rarely observed in those with a CCI of <5, irrespective of age. We did not find an increased risk of ERCP complications in those with CCI ≥5, in contrast to a study of 614 patients where a CCI of ≥2 was recorded in 21% of the cohort and was associated with increased odds of adverse events from ERCP.[[23]] This is despite our cohort being more comorbid, with a CCI ≥5 recorded in 36.6%. Although CCI may have a role in risk stratification, we agree with Galeazzi et al. that a multidomain, comprehensive geriatric assessment should be considered to understand the patient beyond medical history or fitness level.[[24]]

A prior systematic review has demonstrated cardiopulmonary complications as the most common ERCP complication among nonagenarians.[[25]] Our study did not attribute deaths to cardiopulmonary complications; however, we collected data from hospital records and death certificates which may overlook short-term cardiopulmonary events. We should note that most procedures in our study were completed with conscious sedation utilising a combination of midazolam and fentanyl, which may differ from international literature where propofol or general anaesthesia may be employed more frequently. In one randomised study, propofol sedation was associated with a shorter recovery time and less hypoxic events among high-risk octogenarians undergoing ERCP.[[26]]

The main limitation of our study was the single-centre retrospective design. Future prospective studies would help explore the full spectrum of risks in the elderly, including cardiopulmonary adverse events. Due to a lack of a non-interventional control group, the clinical course of elderly patients not undergoing ERCP was not explored. While this may lead to selection bias, a randomised study of this nature is unlikely to happen as it would not be ethical to withhold critical ERCP routinely.

In conclusion, ERCP is relatively safe in elderly patients and should not be withheld based on age alone. The higher prevalence of comorbidities in the elderly should be considered to avoid subjecting vulnerable individuals with a short life expectancy to procedures where potential benefits outweigh the risk of harm.

Summary

Abstract

Aim

To ascertain if endoscopic retrograde cholangiopancreatography (ERCP) in the elderly is associated with an increased risk of complications.

Method

Retrospective study of 509 consecutive ERCPs on 338 patients in one year (2019–2020). Patients were categorised as >75 years old (elderly test group) or ≤75 (controls). The primary outcome was ERCP complications. Secondary outcomes were the length of hospital stay after complications, intensive care admissions, and all-cause mortality at 30 and 90 days.

Results

Forty-four complications occurred in a group of 42 (8%) patients; 11 (2%) were severe, including four deaths. The most common complication was pancreatitis n=33 (6%). There was no difference in complication rates between the elderly and younger controls. Length of stay after complications was similar (median five versus four days; p=0.354). All-cause mortality was higher in the elderly at 30-days (8.5% versus 2%; p=0.002) and 90-days (19.7% versus 6.9%; p=0.001), mostly attributed to malignancy. Logistic analysis showed that neither age >75 years nor Charlson Comorbidity Index (CCI) ≥5 was associated with post-ERCP pancreatitis, but a CCI≥5 strongly increased the odds of death at 90-days (AOR=74.44; 95% confidence interval (CI): 9.78- 566.38, p<0.001).

Conclusion

ERCP is relatively safe in elderly patients, but comorbidities should be considered to avoid subjecting vulnerable individuals with a short life expectancy to unnecessary procedures.

Author Information

Kirsty Macfarlane: Gastroenterology Fellow, Department of Gastroenterology, Auckland City Hospital, New Zealand. Reuben Wilson: Medical Registrar, Department of Medicine, Auckland City Hospital, New Zealand. Nicholas J Fischer, FRACS: Department of Hepatobiliary & Pancreatic Surgery. Royal Surrey County Hospital. United Kingdom. Henry Wei: Consultant Gastroenterologist, Department of Gastroenterology, Auckland City Hospital, New Zealand; Faculty of Medicine, University of Auckland, New Zealand.

Acknowledgements

We are grateful to the outstanding endoscopy team at Middlemore Hospital for their assistance and data collection during these procedures.

Correspondence

Dr Henry Wei: C/O Department of Gastroenterology, Level 6 support building, Auckland City Hospital, 2 Park Road, Grafton, New Zealand.

Correspondence Email

Henry.Wei@adhb.govt.nz

Competing Interests

Nil.

1) Gordon V, Chowdhury A, Keim S. Etiology and Comorbidity Diagnoses Effect on Outcomes for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Cureus. 2020 Sep 2;12(9):e10209.

2) Mashiana HS, Jayaraj M, Liu X, Mohan BP, Azab M, Ohning G. Safety of ERCP in Elderly Patients: A Systematic Review and Meta-Analysis [Internet]. 2017. Available from: www.nature.com/ajg.

3) Clark C, Coe A, Fino N, Pawa R. Endoscopic retrograde cholangiopancreatography in octogenarians: A population-based study using the nationwide inpatient sample. Endosc Int Open. 2016 Jun;4(6):E624-30.

4) Siegel JH, Kasmin FE. Biliary tract diseases in the elderly: management and outcomes. Gut. 1997 Oct;41(4):433-5.

5) Hu L, Sun X, Hao J, Xie T, Liu M, Xin L, et al. Long-term follow-up of therapeutic ERCP in 78 patients aged 90 years or older. Sci Rep. 2014 May 13;4:4918.

6) Asada S, Douhara A, Ueno H, Murata K, Yanase K, Yoshiji H. Efficacy and safety of ERCP in elderly patients with an ECOG performance status of 3 4. World Academy of Sciences Journal. 2020 Jan 30;2(1):28-34.

7) Szary NM, Al-Kawas FH. Complications of endoscopic retrograde cholangiopancreatography: how to avoid and manage them. Gastroenterol Hepatol (N Y). 2013 Aug;9(8):496-504.

8) Kalaitzakis E. All-cause mortality after ERCP. Endoscopy. 2016 Nov;48(11):987-94.

9) Finkelmeier F, Tal A, Ajouaou M, Filmann N, Zeuzem S, Waidmann O, et al. ERCP in elderly patients: increased risk of sedation adverse events but low frequency of post-ERCP pancreatitis. Gastrointest Endosc. 2015 Dec;82(6):1051-9.

10) Sahar N, la Selva D, Gluck M, Gan SI, Irani S, Larsen M, et al. The ASGE grading system for ERCP can predict success and complication rates in a tertiary referral hospital. Surg Endosc. 2019;33(2):448-53.

11) Cotton PB, Eisen G, Romagnuolo J, Vargo J, Baron T, Tarnasky P, et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc. 2011 May;73(5):868-74.

12) Overview A. Demographic Profile: 2018 Census, Population of Counties Manukau. 2021.

13) Charlson ME, Carrozzino D, Guidi J, Patierno C. Charlson Comorbidity Index: A Critical Review of Clinimetric Properties. Psychother Psychosom. 2022;91(1):8-35.

14) Birim Ö, Kappetein AP, Bogers AJJC. Charlson comorbidity index as a predictor of long-term outcome after surgery for nonsmall cell lung cancer. Eur J Cardiothorac Surg. 2005 Nov;28(5):75962.

15) Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11.

16) Cotton PB. Cannulation of the papilla of Vater by endoscopy and retrograde cholangiopancreatography (ERCP). Gut. 1972 Dec;13(12):1014-25.

17) Niu F, Liu YD, Chen RX, Niu YJ. Safety and efficacy of enhanced recovery after surgery in elderly patients after therapeutic endoscopic retrograde cholangiopancreatography. Wideochir Inne Tech Maloinwazyjne. 2019 Sep;14(3):394-400.

18) Deans GT, Sedman P, Martin DF, Royston CM, Leow CK, Thomas WE, et al. Are complications of endoscopic sphincterotomy age related? Gut. 1997 Oct;41(4):545-8.

19) Agarwal N. Endoscopic management of acute cholangitis in elderly patients. World Journal of Gastroenterology. 2006 Oct 28;12(40):6551-5.

20) Mitchell RMS, O'Connor F, Dickey W. Endoscopic Retrograde Cholangiopancreatography Is Safe and Effective in Patients 90 Years of Age and Older. J Clin Gastroenterol. 2003 Jan;36(1):72-4.

21) Enochsson L, Swahn F, Arnelo U, Nilsson M, Löhr M, Persson G. Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP. GastrointestEndosc. 2010 Dec;72(6):1175-84, 1184.e1-3.

22) Bodger K, Bowering K, Sarkar S, Thompson E, Pearson MG. All-cause mortality after first ERCP in England: clinically guided analysis of hospital episode statistics with linkage to registry of death. Gastrointest Endosc. 2011 Oct;74(4):825-33.

23) Tabak F, Wang HS, Li QP, Ge XX, Wang F, Ji GZ, et al. Endoscopic retrograde cholangiopancreatography in elderly patients: Difficult cannulation and adverse events. World J Clin Cases. 2020 Jul 26;8(14):2988-99.

24) Galeazzi M, Mazzola P, Valcarcel B, Bellelli G, Dinelli M, Pasinetti GM, et al. Endoscopic retrograde cholangiopancreatography in the elderly: Results of a retrospective study and a geriatricians' point of view. BMC Gastroenterol. 2018 Mar 14;18(1):38.

25) Day L, Lin L, Somsouk M. Adverse events in older patients undergoing ERCP: a systematic review and meta-analysis. Endosc Int Open. 2014 Mar 7;2(1):E28–36.

26) Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomised, controlled study. Am J Gastroenterol. 2005 Sep;100(9):1957-63.

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Endoscopic retrograde cholangiopancreatography (ERCP) is the first-line therapy for choledocholithiasis and associated pancreaticobiliary pathology, with over half a million procedures annually in the United States alone.[[1]] Pancreaticobiliary pathology is more common in the elderly, with an estimated 10–20% of elderly patients presenting with cholecystitis having coexisting choledocholithiasis, compared to 5% in the general population. In addition, the incidence of ductal stones in elderly patients undergoing emergency cholecystectomy approaches 50%.[[2,3]] Due to an ageing worldwide population, ERCP is increasingly utilised in the elderly as a therapeutic tool.[[3–6]] Despite this, ERCP in the elderly is purported to be associated with increased procedural difficulty and periprocedural adverse events. The increased risk might be expected due to a higher prevalence of frailty and comorbidities in this population, and the safety of ERCP in the elderly is often debated, with age frequently cited as a contraindication.[[7]]

Despite the perceived risks of ERCP in the elderly, there are limited comparative studies on outcomes. Literature on the safety and complication rates of older patients undergoing ERCP is conflicting. A systematic review of 18 studies by Harmeet et al. in 2017 concluded that ERCP was safe in the elderly, with higher rates of post-ERCP pancreatitis reported in younger patients.[[2,7]] Another study of octogenarians undergoing ERCP with a mean age of 84 years cited a mortality rate of 3.1%, which is considerably lower than the standard quoted mortality rate of 5%.[[3,8]] In contrast, high rates of post-ERCP mortality were reported by Kalaitzakis et al. in the very elderly >80 years, mainly due to underlying diseases, notably cancer.[[8]] Sedation for ERCP is also associated with increased risks in the elderly and may contribute to periprocedural morbidity and mortality.[[9]]

To our knowledge, there is no comparative outcomes data for elderly patients undergoing ERCP in New Zealand. Increased understanding of the complication and outcomes of ERCP could help clinicians select the best therapeutic approach and potentially avoid exposing vulnerable patients to risky interventions.

Methods

The records of 509 consecutive ERCP procedures performed between September 2019 and September 2020 were retrospectively reviewed. Procedural details were captured from endoscopy reports via ProVation® MD software. In addition, a comprehensive assessment of clinical records, including radiology and laboratory data, was completed. Specific data collected included demographics, procedural indication, American Society for Gastrointestinal Endoscopy (ASGE) complexity score,[[10,11]] procedural techniques and whether non-steroidal anti-inflammatories (NSAIDs) were prescribed. Comorbidities were classified using the Charlson Comorbidity Index (CCI) below. The cause of death was obtained via clinical records. Patients were divided into elderly >75 years and controls ≤75 years old for analysis and comparison. Ethics approval was obtained from the Health and Disability Ethics Committee.

All procedures were completed by four consultant gastroenterologists and a senior endoscopy fellow at Middlemore Hospital. Middlemore Hospital is a tertiary referral centre for Counties Manukau District Health Board in Auckland, New Zealand and services approximately 567,000 people, representing 11% of the total New Zealand population in 2018.[[12]] Both emergency and elective ERCP were included. The majority utilised conscious sedation with a combination of midazolam and fentanyl as directed by the endoscopist. A small number of procedures were conducted with propofol or general anaesthesia. Rectal NSAIDs with diclofenac were prescribed at the start of each procedure for post-ERCP pancreatitis (PEP) prophylaxis at the endoscopist’s discretion. Cannulation was typically carried out using a guidewire-assisted technique with a sphincterotome; other interventions such as needle-knife or trans-pancreatic precut sphincterotomy, dilatation and stenting were carried out depending on the requirements of each procedure and the endoscopist expertise.

Charlson Comorbidity Index

CCI is an internationally recognised method of categorising comorbidities based on the International Classification of Diseases. Comorbidities are weighted based on the adjusted risk of mortality or resource use at one year, and the sum of all the weights results in a single comorbidity score for each patient.[[13,14]] Nineteen conditions are used in the scoring system and given a weight based on the estimated mortality hazard ratio from a Cox proportional hazards model. A score of zero indicates no comorbidities, whilst a score of five or more may be considered highly comorbid. Studies have shown that using the CCI as a composite score is a better predictor of prognosis than individual comorbidities alone.[[14]]

Primary and secondary outcomes

The primary outcome was complications from ERCP based on clinical records, laboratory findings and radiology results. Pancreatitis was classified using the revised Atlanta classification for pancreatitis, which requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis; (b) serum amylase or lipase level greater than three times the upper normal value; or (c) characteristic imaging findings.[[15]] In addition, the Cotton criteria were used for grading bleeding, perforation and sepsis.[[10,16]] We also examined variables that predicted PEP in a multivariate analysis model.

Secondary outcomes were the length of hospital stay after complications from ERCP, intensive care admissions, and all-cause mortality at 30 and 90 days following ERCP.

Statistics

Our sample size was greater than the estimated sample size of 400 procedures required to detect a 10% difference between study groups for combined adverse events from ERCP (α 0.05; statistical power 80%; 1:3 enrolment ratio).

Fisher’s exact test was used for categorical variables, and the Mann–Whitney U test for non-categorical variables was performed to compare study groups. Statistical significance was set at the p value <0.05 (two-sided) level. Potential variables for ERCP complications were entered into a multivariate logistic regression analysis with odds ratio adjusted for potential confounders. Mortality results were presented using Kaplan–Meier survival curves. Data analysis was completed using IBM Statistics 26 program (SPSS Inc, Chicago, III).

Results

A total of 509 ERCP procedures performed on 338 patients were included. The mean age was 61 years (range 16–93). The elderly >75 years cohort comprised 23% (117/509) of the total procedures. Compared to the younger cohort, the elderly were more likely to be male (53.8% vs 39.8%; p=0.007) and of NZ European ethnicity (51.3% vs 35.2%; p=0.002). The elderly cohort also had a significantly higher CCI (mean 6.25 vs 3.17). There was no significant difference in ERCP indications and ASGE complexity score between the elderly and young groups. The most common indication for ERCP was choledocholithiasis (43%), ascending cholangitis (16.3%), pancreatic cancer (9.4%), gallstone pancreatitis (6.9%), biliary cancer (5.5%) and jaundice—cause not specified (5.5%). The elderly group were less likely to receive NSAIDs at ERCP (9.4% vs 19.3%; p=0.002). Other procedural characteristics were similar between groups (Table 1).

Complications from ERCP

Forty-four complications occurred in 42 (8%) patients, 11 (2%) of which were severe, including four deaths. Pancreatitis occurred in six (5.1%) patients of the elderly versus 27 (6.9%) patients in the younger cohort, with no statistical difference (p=0.669). In addition, there was no difference in the total number of complications, intensive care admissions and length of hospital stay after complications (median four days in elderly vs five days in the younger cohort; p=0.354) (see Table 2). Complication rates did not differ between senior endoscopists or in cases involving a fellow.

Predictors of PEP

Multivariate logistical regression showed that neither age >75 years nor CCI ≥5 was associated with an increased risk of PEP. After adjusting for other variables, an increased risk of PEP was observed in females (adjusted odds ratio AOR=2.93; 95% confidence interval (CI):1.12–7.67; p=0.028), pre-cut sphincterotomy (AOR=6.82; 95% CI:1.82–25.6; p=0.004) and pancreatic sphincterotomy (AOR=23.65; 95% CI: 3.74–149.7; p=0.001). Interestingly, ASGE complexity score was not associated with an increased risk of PEP; however, NSAID use was associated with PEP (AOR=4.28; 95% CI: 1.89–9.7; p=0.001) (see Table 3).

30- and 90-day all-cause mortality

At 30-days post ERCP, there were 22 deaths from any cause, representing 4.32% of the study population. Fifty deaths (9.8%) were observed at 90 days post ERCP. All-cause mortality was significantly higher in the elderly group at 30 days (8.5% vs 2%; p=0.002) and 90-days (19.7% vs 6.9%; p<0.001). Causes of death at 90 days are summarised in Figure 1.

After adjusting for sex and ethnicity, multivariate logistical regression showed that a CCI ≥5 significantly increased all-cause mortality at 90 days (AOR=74.44; 95% CI: 9.78–566.38; p<0.001), followed by malignant biliary disease (AOR=2.89; 95% CI: 1.44–5.79; p=0.003) and age >75 years (AOR=2.28; 95% CI: 1.14–4.55; p=0.02). Complications from ERCP did not significantly increase the odds of death at 90-days in our model (see Table 4). Considering patients in both groups, CCI ≥5 increased the odds of death at 90 days (see Figure 2).

View Tables 1–4 & Figures 1–2.

Discussion

Our finding is the first of its kind in New Zealand and adds to the growing literature on ERCP in the elderly. There was no difference in ERCP complication rates between the elderly and younger patients. This is consistent with an earlier systematic review that demonstrated incidence rates of ERCP complications for elderly patients similar to most reported literature.[[17]] While several studies have established the safety and efficacy of ERCP in the elderly, they had limitations with lacking a comparator group or including outcomes for elderly patients as young as 60 years old.[[18–20]]

Counter-intuitively, NSAID use was associated with increased pancreatitis in multivariate analysis. At the time of this study, NSAID use was at the endoscopist’s discretion and typically only for patients considered at high risk of PEP. The overall NSAID use was significantly lower in the elderly cohort, and this should increase the risk of pancreatitis in the elderly, but our findings show similar rates of pancreatitis versus the younger cohort. Advancing age has been shown to have a protective role against the development of PEP in prior studies and, perhaps, offset the effects of lower NSAID use amongst the elderly.[[2]]

While ERCP-related mortality is well-described, there is a lack of comparative data on all-cause mortality in the elderly and few studies that incorporate a standardised comorbidity index. We reported a 9.8% all-cause mortality at 90 days post ERCP, comparable to published data from international registries.[[8,21,22]] Mortality post ERCP was driven primarily by comorbidities, and a CCI of ≥5 was the strongest predictor of death. 90-day mortality was rarely observed in those with a CCI of <5, irrespective of age. We did not find an increased risk of ERCP complications in those with CCI ≥5, in contrast to a study of 614 patients where a CCI of ≥2 was recorded in 21% of the cohort and was associated with increased odds of adverse events from ERCP.[[23]] This is despite our cohort being more comorbid, with a CCI ≥5 recorded in 36.6%. Although CCI may have a role in risk stratification, we agree with Galeazzi et al. that a multidomain, comprehensive geriatric assessment should be considered to understand the patient beyond medical history or fitness level.[[24]]

A prior systematic review has demonstrated cardiopulmonary complications as the most common ERCP complication among nonagenarians.[[25]] Our study did not attribute deaths to cardiopulmonary complications; however, we collected data from hospital records and death certificates which may overlook short-term cardiopulmonary events. We should note that most procedures in our study were completed with conscious sedation utilising a combination of midazolam and fentanyl, which may differ from international literature where propofol or general anaesthesia may be employed more frequently. In one randomised study, propofol sedation was associated with a shorter recovery time and less hypoxic events among high-risk octogenarians undergoing ERCP.[[26]]

The main limitation of our study was the single-centre retrospective design. Future prospective studies would help explore the full spectrum of risks in the elderly, including cardiopulmonary adverse events. Due to a lack of a non-interventional control group, the clinical course of elderly patients not undergoing ERCP was not explored. While this may lead to selection bias, a randomised study of this nature is unlikely to happen as it would not be ethical to withhold critical ERCP routinely.

In conclusion, ERCP is relatively safe in elderly patients and should not be withheld based on age alone. The higher prevalence of comorbidities in the elderly should be considered to avoid subjecting vulnerable individuals with a short life expectancy to procedures where potential benefits outweigh the risk of harm.

Summary

Abstract

Aim

To ascertain if endoscopic retrograde cholangiopancreatography (ERCP) in the elderly is associated with an increased risk of complications.

Method

Retrospective study of 509 consecutive ERCPs on 338 patients in one year (2019–2020). Patients were categorised as >75 years old (elderly test group) or ≤75 (controls). The primary outcome was ERCP complications. Secondary outcomes were the length of hospital stay after complications, intensive care admissions, and all-cause mortality at 30 and 90 days.

Results

Forty-four complications occurred in a group of 42 (8%) patients; 11 (2%) were severe, including four deaths. The most common complication was pancreatitis n=33 (6%). There was no difference in complication rates between the elderly and younger controls. Length of stay after complications was similar (median five versus four days; p=0.354). All-cause mortality was higher in the elderly at 30-days (8.5% versus 2%; p=0.002) and 90-days (19.7% versus 6.9%; p=0.001), mostly attributed to malignancy. Logistic analysis showed that neither age >75 years nor Charlson Comorbidity Index (CCI) ≥5 was associated with post-ERCP pancreatitis, but a CCI≥5 strongly increased the odds of death at 90-days (AOR=74.44; 95% confidence interval (CI): 9.78- 566.38, p<0.001).

Conclusion

ERCP is relatively safe in elderly patients, but comorbidities should be considered to avoid subjecting vulnerable individuals with a short life expectancy to unnecessary procedures.

Author Information

Kirsty Macfarlane: Gastroenterology Fellow, Department of Gastroenterology, Auckland City Hospital, New Zealand. Reuben Wilson: Medical Registrar, Department of Medicine, Auckland City Hospital, New Zealand. Nicholas J Fischer, FRACS: Department of Hepatobiliary & Pancreatic Surgery. Royal Surrey County Hospital. United Kingdom. Henry Wei: Consultant Gastroenterologist, Department of Gastroenterology, Auckland City Hospital, New Zealand; Faculty of Medicine, University of Auckland, New Zealand.

Acknowledgements

We are grateful to the outstanding endoscopy team at Middlemore Hospital for their assistance and data collection during these procedures.

Correspondence

Dr Henry Wei: C/O Department of Gastroenterology, Level 6 support building, Auckland City Hospital, 2 Park Road, Grafton, New Zealand.

Correspondence Email

Henry.Wei@adhb.govt.nz

Competing Interests

Nil.

1) Gordon V, Chowdhury A, Keim S. Etiology and Comorbidity Diagnoses Effect on Outcomes for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Cureus. 2020 Sep 2;12(9):e10209.

2) Mashiana HS, Jayaraj M, Liu X, Mohan BP, Azab M, Ohning G. Safety of ERCP in Elderly Patients: A Systematic Review and Meta-Analysis [Internet]. 2017. Available from: www.nature.com/ajg.

3) Clark C, Coe A, Fino N, Pawa R. Endoscopic retrograde cholangiopancreatography in octogenarians: A population-based study using the nationwide inpatient sample. Endosc Int Open. 2016 Jun;4(6):E624-30.

4) Siegel JH, Kasmin FE. Biliary tract diseases in the elderly: management and outcomes. Gut. 1997 Oct;41(4):433-5.

5) Hu L, Sun X, Hao J, Xie T, Liu M, Xin L, et al. Long-term follow-up of therapeutic ERCP in 78 patients aged 90 years or older. Sci Rep. 2014 May 13;4:4918.

6) Asada S, Douhara A, Ueno H, Murata K, Yanase K, Yoshiji H. Efficacy and safety of ERCP in elderly patients with an ECOG performance status of 3 4. World Academy of Sciences Journal. 2020 Jan 30;2(1):28-34.

7) Szary NM, Al-Kawas FH. Complications of endoscopic retrograde cholangiopancreatography: how to avoid and manage them. Gastroenterol Hepatol (N Y). 2013 Aug;9(8):496-504.

8) Kalaitzakis E. All-cause mortality after ERCP. Endoscopy. 2016 Nov;48(11):987-94.

9) Finkelmeier F, Tal A, Ajouaou M, Filmann N, Zeuzem S, Waidmann O, et al. ERCP in elderly patients: increased risk of sedation adverse events but low frequency of post-ERCP pancreatitis. Gastrointest Endosc. 2015 Dec;82(6):1051-9.

10) Sahar N, la Selva D, Gluck M, Gan SI, Irani S, Larsen M, et al. The ASGE grading system for ERCP can predict success and complication rates in a tertiary referral hospital. Surg Endosc. 2019;33(2):448-53.

11) Cotton PB, Eisen G, Romagnuolo J, Vargo J, Baron T, Tarnasky P, et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc. 2011 May;73(5):868-74.

12) Overview A. Demographic Profile: 2018 Census, Population of Counties Manukau. 2021.

13) Charlson ME, Carrozzino D, Guidi J, Patierno C. Charlson Comorbidity Index: A Critical Review of Clinimetric Properties. Psychother Psychosom. 2022;91(1):8-35.

14) Birim Ö, Kappetein AP, Bogers AJJC. Charlson comorbidity index as a predictor of long-term outcome after surgery for nonsmall cell lung cancer. Eur J Cardiothorac Surg. 2005 Nov;28(5):75962.

15) Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11.

16) Cotton PB. Cannulation of the papilla of Vater by endoscopy and retrograde cholangiopancreatography (ERCP). Gut. 1972 Dec;13(12):1014-25.

17) Niu F, Liu YD, Chen RX, Niu YJ. Safety and efficacy of enhanced recovery after surgery in elderly patients after therapeutic endoscopic retrograde cholangiopancreatography. Wideochir Inne Tech Maloinwazyjne. 2019 Sep;14(3):394-400.

18) Deans GT, Sedman P, Martin DF, Royston CM, Leow CK, Thomas WE, et al. Are complications of endoscopic sphincterotomy age related? Gut. 1997 Oct;41(4):545-8.

19) Agarwal N. Endoscopic management of acute cholangitis in elderly patients. World Journal of Gastroenterology. 2006 Oct 28;12(40):6551-5.

20) Mitchell RMS, O'Connor F, Dickey W. Endoscopic Retrograde Cholangiopancreatography Is Safe and Effective in Patients 90 Years of Age and Older. J Clin Gastroenterol. 2003 Jan;36(1):72-4.

21) Enochsson L, Swahn F, Arnelo U, Nilsson M, Löhr M, Persson G. Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP. GastrointestEndosc. 2010 Dec;72(6):1175-84, 1184.e1-3.

22) Bodger K, Bowering K, Sarkar S, Thompson E, Pearson MG. All-cause mortality after first ERCP in England: clinically guided analysis of hospital episode statistics with linkage to registry of death. Gastrointest Endosc. 2011 Oct;74(4):825-33.

23) Tabak F, Wang HS, Li QP, Ge XX, Wang F, Ji GZ, et al. Endoscopic retrograde cholangiopancreatography in elderly patients: Difficult cannulation and adverse events. World J Clin Cases. 2020 Jul 26;8(14):2988-99.

24) Galeazzi M, Mazzola P, Valcarcel B, Bellelli G, Dinelli M, Pasinetti GM, et al. Endoscopic retrograde cholangiopancreatography in the elderly: Results of a retrospective study and a geriatricians' point of view. BMC Gastroenterol. 2018 Mar 14;18(1):38.

25) Day L, Lin L, Somsouk M. Adverse events in older patients undergoing ERCP: a systematic review and meta-analysis. Endosc Int Open. 2014 Mar 7;2(1):E28–36.

26) Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomised, controlled study. Am J Gastroenterol. 2005 Sep;100(9):1957-63.

For the PDF of this article,
contact nzmj@nzma.org.nz

View Article PDF

Endoscopic retrograde cholangiopancreatography (ERCP) is the first-line therapy for choledocholithiasis and associated pancreaticobiliary pathology, with over half a million procedures annually in the United States alone.[[1]] Pancreaticobiliary pathology is more common in the elderly, with an estimated 10–20% of elderly patients presenting with cholecystitis having coexisting choledocholithiasis, compared to 5% in the general population. In addition, the incidence of ductal stones in elderly patients undergoing emergency cholecystectomy approaches 50%.[[2,3]] Due to an ageing worldwide population, ERCP is increasingly utilised in the elderly as a therapeutic tool.[[3–6]] Despite this, ERCP in the elderly is purported to be associated with increased procedural difficulty and periprocedural adverse events. The increased risk might be expected due to a higher prevalence of frailty and comorbidities in this population, and the safety of ERCP in the elderly is often debated, with age frequently cited as a contraindication.[[7]]

Despite the perceived risks of ERCP in the elderly, there are limited comparative studies on outcomes. Literature on the safety and complication rates of older patients undergoing ERCP is conflicting. A systematic review of 18 studies by Harmeet et al. in 2017 concluded that ERCP was safe in the elderly, with higher rates of post-ERCP pancreatitis reported in younger patients.[[2,7]] Another study of octogenarians undergoing ERCP with a mean age of 84 years cited a mortality rate of 3.1%, which is considerably lower than the standard quoted mortality rate of 5%.[[3,8]] In contrast, high rates of post-ERCP mortality were reported by Kalaitzakis et al. in the very elderly >80 years, mainly due to underlying diseases, notably cancer.[[8]] Sedation for ERCP is also associated with increased risks in the elderly and may contribute to periprocedural morbidity and mortality.[[9]]

To our knowledge, there is no comparative outcomes data for elderly patients undergoing ERCP in New Zealand. Increased understanding of the complication and outcomes of ERCP could help clinicians select the best therapeutic approach and potentially avoid exposing vulnerable patients to risky interventions.

Methods

The records of 509 consecutive ERCP procedures performed between September 2019 and September 2020 were retrospectively reviewed. Procedural details were captured from endoscopy reports via ProVation® MD software. In addition, a comprehensive assessment of clinical records, including radiology and laboratory data, was completed. Specific data collected included demographics, procedural indication, American Society for Gastrointestinal Endoscopy (ASGE) complexity score,[[10,11]] procedural techniques and whether non-steroidal anti-inflammatories (NSAIDs) were prescribed. Comorbidities were classified using the Charlson Comorbidity Index (CCI) below. The cause of death was obtained via clinical records. Patients were divided into elderly >75 years and controls ≤75 years old for analysis and comparison. Ethics approval was obtained from the Health and Disability Ethics Committee.

All procedures were completed by four consultant gastroenterologists and a senior endoscopy fellow at Middlemore Hospital. Middlemore Hospital is a tertiary referral centre for Counties Manukau District Health Board in Auckland, New Zealand and services approximately 567,000 people, representing 11% of the total New Zealand population in 2018.[[12]] Both emergency and elective ERCP were included. The majority utilised conscious sedation with a combination of midazolam and fentanyl as directed by the endoscopist. A small number of procedures were conducted with propofol or general anaesthesia. Rectal NSAIDs with diclofenac were prescribed at the start of each procedure for post-ERCP pancreatitis (PEP) prophylaxis at the endoscopist’s discretion. Cannulation was typically carried out using a guidewire-assisted technique with a sphincterotome; other interventions such as needle-knife or trans-pancreatic precut sphincterotomy, dilatation and stenting were carried out depending on the requirements of each procedure and the endoscopist expertise.

Charlson Comorbidity Index

CCI is an internationally recognised method of categorising comorbidities based on the International Classification of Diseases. Comorbidities are weighted based on the adjusted risk of mortality or resource use at one year, and the sum of all the weights results in a single comorbidity score for each patient.[[13,14]] Nineteen conditions are used in the scoring system and given a weight based on the estimated mortality hazard ratio from a Cox proportional hazards model. A score of zero indicates no comorbidities, whilst a score of five or more may be considered highly comorbid. Studies have shown that using the CCI as a composite score is a better predictor of prognosis than individual comorbidities alone.[[14]]

Primary and secondary outcomes

The primary outcome was complications from ERCP based on clinical records, laboratory findings and radiology results. Pancreatitis was classified using the revised Atlanta classification for pancreatitis, which requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis; (b) serum amylase or lipase level greater than three times the upper normal value; or (c) characteristic imaging findings.[[15]] In addition, the Cotton criteria were used for grading bleeding, perforation and sepsis.[[10,16]] We also examined variables that predicted PEP in a multivariate analysis model.

Secondary outcomes were the length of hospital stay after complications from ERCP, intensive care admissions, and all-cause mortality at 30 and 90 days following ERCP.

Statistics

Our sample size was greater than the estimated sample size of 400 procedures required to detect a 10% difference between study groups for combined adverse events from ERCP (α 0.05; statistical power 80%; 1:3 enrolment ratio).

Fisher’s exact test was used for categorical variables, and the Mann–Whitney U test for non-categorical variables was performed to compare study groups. Statistical significance was set at the p value <0.05 (two-sided) level. Potential variables for ERCP complications were entered into a multivariate logistic regression analysis with odds ratio adjusted for potential confounders. Mortality results were presented using Kaplan–Meier survival curves. Data analysis was completed using IBM Statistics 26 program (SPSS Inc, Chicago, III).

Results

A total of 509 ERCP procedures performed on 338 patients were included. The mean age was 61 years (range 16–93). The elderly >75 years cohort comprised 23% (117/509) of the total procedures. Compared to the younger cohort, the elderly were more likely to be male (53.8% vs 39.8%; p=0.007) and of NZ European ethnicity (51.3% vs 35.2%; p=0.002). The elderly cohort also had a significantly higher CCI (mean 6.25 vs 3.17). There was no significant difference in ERCP indications and ASGE complexity score between the elderly and young groups. The most common indication for ERCP was choledocholithiasis (43%), ascending cholangitis (16.3%), pancreatic cancer (9.4%), gallstone pancreatitis (6.9%), biliary cancer (5.5%) and jaundice—cause not specified (5.5%). The elderly group were less likely to receive NSAIDs at ERCP (9.4% vs 19.3%; p=0.002). Other procedural characteristics were similar between groups (Table 1).

Complications from ERCP

Forty-four complications occurred in 42 (8%) patients, 11 (2%) of which were severe, including four deaths. Pancreatitis occurred in six (5.1%) patients of the elderly versus 27 (6.9%) patients in the younger cohort, with no statistical difference (p=0.669). In addition, there was no difference in the total number of complications, intensive care admissions and length of hospital stay after complications (median four days in elderly vs five days in the younger cohort; p=0.354) (see Table 2). Complication rates did not differ between senior endoscopists or in cases involving a fellow.

Predictors of PEP

Multivariate logistical regression showed that neither age >75 years nor CCI ≥5 was associated with an increased risk of PEP. After adjusting for other variables, an increased risk of PEP was observed in females (adjusted odds ratio AOR=2.93; 95% confidence interval (CI):1.12–7.67; p=0.028), pre-cut sphincterotomy (AOR=6.82; 95% CI:1.82–25.6; p=0.004) and pancreatic sphincterotomy (AOR=23.65; 95% CI: 3.74–149.7; p=0.001). Interestingly, ASGE complexity score was not associated with an increased risk of PEP; however, NSAID use was associated with PEP (AOR=4.28; 95% CI: 1.89–9.7; p=0.001) (see Table 3).

30- and 90-day all-cause mortality

At 30-days post ERCP, there were 22 deaths from any cause, representing 4.32% of the study population. Fifty deaths (9.8%) were observed at 90 days post ERCP. All-cause mortality was significantly higher in the elderly group at 30 days (8.5% vs 2%; p=0.002) and 90-days (19.7% vs 6.9%; p<0.001). Causes of death at 90 days are summarised in Figure 1.

After adjusting for sex and ethnicity, multivariate logistical regression showed that a CCI ≥5 significantly increased all-cause mortality at 90 days (AOR=74.44; 95% CI: 9.78–566.38; p<0.001), followed by malignant biliary disease (AOR=2.89; 95% CI: 1.44–5.79; p=0.003) and age >75 years (AOR=2.28; 95% CI: 1.14–4.55; p=0.02). Complications from ERCP did not significantly increase the odds of death at 90-days in our model (see Table 4). Considering patients in both groups, CCI ≥5 increased the odds of death at 90 days (see Figure 2).

View Tables 1–4 & Figures 1–2.

Discussion

Our finding is the first of its kind in New Zealand and adds to the growing literature on ERCP in the elderly. There was no difference in ERCP complication rates between the elderly and younger patients. This is consistent with an earlier systematic review that demonstrated incidence rates of ERCP complications for elderly patients similar to most reported literature.[[17]] While several studies have established the safety and efficacy of ERCP in the elderly, they had limitations with lacking a comparator group or including outcomes for elderly patients as young as 60 years old.[[18–20]]

Counter-intuitively, NSAID use was associated with increased pancreatitis in multivariate analysis. At the time of this study, NSAID use was at the endoscopist’s discretion and typically only for patients considered at high risk of PEP. The overall NSAID use was significantly lower in the elderly cohort, and this should increase the risk of pancreatitis in the elderly, but our findings show similar rates of pancreatitis versus the younger cohort. Advancing age has been shown to have a protective role against the development of PEP in prior studies and, perhaps, offset the effects of lower NSAID use amongst the elderly.[[2]]

While ERCP-related mortality is well-described, there is a lack of comparative data on all-cause mortality in the elderly and few studies that incorporate a standardised comorbidity index. We reported a 9.8% all-cause mortality at 90 days post ERCP, comparable to published data from international registries.[[8,21,22]] Mortality post ERCP was driven primarily by comorbidities, and a CCI of ≥5 was the strongest predictor of death. 90-day mortality was rarely observed in those with a CCI of <5, irrespective of age. We did not find an increased risk of ERCP complications in those with CCI ≥5, in contrast to a study of 614 patients where a CCI of ≥2 was recorded in 21% of the cohort and was associated with increased odds of adverse events from ERCP.[[23]] This is despite our cohort being more comorbid, with a CCI ≥5 recorded in 36.6%. Although CCI may have a role in risk stratification, we agree with Galeazzi et al. that a multidomain, comprehensive geriatric assessment should be considered to understand the patient beyond medical history or fitness level.[[24]]

A prior systematic review has demonstrated cardiopulmonary complications as the most common ERCP complication among nonagenarians.[[25]] Our study did not attribute deaths to cardiopulmonary complications; however, we collected data from hospital records and death certificates which may overlook short-term cardiopulmonary events. We should note that most procedures in our study were completed with conscious sedation utilising a combination of midazolam and fentanyl, which may differ from international literature where propofol or general anaesthesia may be employed more frequently. In one randomised study, propofol sedation was associated with a shorter recovery time and less hypoxic events among high-risk octogenarians undergoing ERCP.[[26]]

The main limitation of our study was the single-centre retrospective design. Future prospective studies would help explore the full spectrum of risks in the elderly, including cardiopulmonary adverse events. Due to a lack of a non-interventional control group, the clinical course of elderly patients not undergoing ERCP was not explored. While this may lead to selection bias, a randomised study of this nature is unlikely to happen as it would not be ethical to withhold critical ERCP routinely.

In conclusion, ERCP is relatively safe in elderly patients and should not be withheld based on age alone. The higher prevalence of comorbidities in the elderly should be considered to avoid subjecting vulnerable individuals with a short life expectancy to procedures where potential benefits outweigh the risk of harm.

Summary

Abstract

Aim

To ascertain if endoscopic retrograde cholangiopancreatography (ERCP) in the elderly is associated with an increased risk of complications.

Method

Retrospective study of 509 consecutive ERCPs on 338 patients in one year (2019–2020). Patients were categorised as >75 years old (elderly test group) or ≤75 (controls). The primary outcome was ERCP complications. Secondary outcomes were the length of hospital stay after complications, intensive care admissions, and all-cause mortality at 30 and 90 days.

Results

Forty-four complications occurred in a group of 42 (8%) patients; 11 (2%) were severe, including four deaths. The most common complication was pancreatitis n=33 (6%). There was no difference in complication rates between the elderly and younger controls. Length of stay after complications was similar (median five versus four days; p=0.354). All-cause mortality was higher in the elderly at 30-days (8.5% versus 2%; p=0.002) and 90-days (19.7% versus 6.9%; p=0.001), mostly attributed to malignancy. Logistic analysis showed that neither age >75 years nor Charlson Comorbidity Index (CCI) ≥5 was associated with post-ERCP pancreatitis, but a CCI≥5 strongly increased the odds of death at 90-days (AOR=74.44; 95% confidence interval (CI): 9.78- 566.38, p<0.001).

Conclusion

ERCP is relatively safe in elderly patients, but comorbidities should be considered to avoid subjecting vulnerable individuals with a short life expectancy to unnecessary procedures.

Author Information

Kirsty Macfarlane: Gastroenterology Fellow, Department of Gastroenterology, Auckland City Hospital, New Zealand. Reuben Wilson: Medical Registrar, Department of Medicine, Auckland City Hospital, New Zealand. Nicholas J Fischer, FRACS: Department of Hepatobiliary & Pancreatic Surgery. Royal Surrey County Hospital. United Kingdom. Henry Wei: Consultant Gastroenterologist, Department of Gastroenterology, Auckland City Hospital, New Zealand; Faculty of Medicine, University of Auckland, New Zealand.

Acknowledgements

We are grateful to the outstanding endoscopy team at Middlemore Hospital for their assistance and data collection during these procedures.

Correspondence

Dr Henry Wei: C/O Department of Gastroenterology, Level 6 support building, Auckland City Hospital, 2 Park Road, Grafton, New Zealand.

Correspondence Email

Henry.Wei@adhb.govt.nz

Competing Interests

Nil.

1) Gordon V, Chowdhury A, Keim S. Etiology and Comorbidity Diagnoses Effect on Outcomes for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Cureus. 2020 Sep 2;12(9):e10209.

2) Mashiana HS, Jayaraj M, Liu X, Mohan BP, Azab M, Ohning G. Safety of ERCP in Elderly Patients: A Systematic Review and Meta-Analysis [Internet]. 2017. Available from: www.nature.com/ajg.

3) Clark C, Coe A, Fino N, Pawa R. Endoscopic retrograde cholangiopancreatography in octogenarians: A population-based study using the nationwide inpatient sample. Endosc Int Open. 2016 Jun;4(6):E624-30.

4) Siegel JH, Kasmin FE. Biliary tract diseases in the elderly: management and outcomes. Gut. 1997 Oct;41(4):433-5.

5) Hu L, Sun X, Hao J, Xie T, Liu M, Xin L, et al. Long-term follow-up of therapeutic ERCP in 78 patients aged 90 years or older. Sci Rep. 2014 May 13;4:4918.

6) Asada S, Douhara A, Ueno H, Murata K, Yanase K, Yoshiji H. Efficacy and safety of ERCP in elderly patients with an ECOG performance status of 3 4. World Academy of Sciences Journal. 2020 Jan 30;2(1):28-34.

7) Szary NM, Al-Kawas FH. Complications of endoscopic retrograde cholangiopancreatography: how to avoid and manage them. Gastroenterol Hepatol (N Y). 2013 Aug;9(8):496-504.

8) Kalaitzakis E. All-cause mortality after ERCP. Endoscopy. 2016 Nov;48(11):987-94.

9) Finkelmeier F, Tal A, Ajouaou M, Filmann N, Zeuzem S, Waidmann O, et al. ERCP in elderly patients: increased risk of sedation adverse events but low frequency of post-ERCP pancreatitis. Gastrointest Endosc. 2015 Dec;82(6):1051-9.

10) Sahar N, la Selva D, Gluck M, Gan SI, Irani S, Larsen M, et al. The ASGE grading system for ERCP can predict success and complication rates in a tertiary referral hospital. Surg Endosc. 2019;33(2):448-53.

11) Cotton PB, Eisen G, Romagnuolo J, Vargo J, Baron T, Tarnasky P, et al. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc. 2011 May;73(5):868-74.

12) Overview A. Demographic Profile: 2018 Census, Population of Counties Manukau. 2021.

13) Charlson ME, Carrozzino D, Guidi J, Patierno C. Charlson Comorbidity Index: A Critical Review of Clinimetric Properties. Psychother Psychosom. 2022;91(1):8-35.

14) Birim Ö, Kappetein AP, Bogers AJJC. Charlson comorbidity index as a predictor of long-term outcome after surgery for nonsmall cell lung cancer. Eur J Cardiothorac Surg. 2005 Nov;28(5):75962.

15) Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11.

16) Cotton PB. Cannulation of the papilla of Vater by endoscopy and retrograde cholangiopancreatography (ERCP). Gut. 1972 Dec;13(12):1014-25.

17) Niu F, Liu YD, Chen RX, Niu YJ. Safety and efficacy of enhanced recovery after surgery in elderly patients after therapeutic endoscopic retrograde cholangiopancreatography. Wideochir Inne Tech Maloinwazyjne. 2019 Sep;14(3):394-400.

18) Deans GT, Sedman P, Martin DF, Royston CM, Leow CK, Thomas WE, et al. Are complications of endoscopic sphincterotomy age related? Gut. 1997 Oct;41(4):545-8.

19) Agarwal N. Endoscopic management of acute cholangitis in elderly patients. World Journal of Gastroenterology. 2006 Oct 28;12(40):6551-5.

20) Mitchell RMS, O'Connor F, Dickey W. Endoscopic Retrograde Cholangiopancreatography Is Safe and Effective in Patients 90 Years of Age and Older. J Clin Gastroenterol. 2003 Jan;36(1):72-4.

21) Enochsson L, Swahn F, Arnelo U, Nilsson M, Löhr M, Persson G. Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP. GastrointestEndosc. 2010 Dec;72(6):1175-84, 1184.e1-3.

22) Bodger K, Bowering K, Sarkar S, Thompson E, Pearson MG. All-cause mortality after first ERCP in England: clinically guided analysis of hospital episode statistics with linkage to registry of death. Gastrointest Endosc. 2011 Oct;74(4):825-33.

23) Tabak F, Wang HS, Li QP, Ge XX, Wang F, Ji GZ, et al. Endoscopic retrograde cholangiopancreatography in elderly patients: Difficult cannulation and adverse events. World J Clin Cases. 2020 Jul 26;8(14):2988-99.

24) Galeazzi M, Mazzola P, Valcarcel B, Bellelli G, Dinelli M, Pasinetti GM, et al. Endoscopic retrograde cholangiopancreatography in the elderly: Results of a retrospective study and a geriatricians' point of view. BMC Gastroenterol. 2018 Mar 14;18(1):38.

25) Day L, Lin L, Somsouk M. Adverse events in older patients undergoing ERCP: a systematic review and meta-analysis. Endosc Int Open. 2014 Mar 7;2(1):E28–36.

26) Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomised, controlled study. Am J Gastroenterol. 2005 Sep;100(9):1957-63.

Contact diana@nzma.org.nz
for the PDF of this article

View Article PDF

Endoscopic retrograde cholangiopancreatography (ERCP) is the first-line therapy for choledocholithiasis and associated pancreaticobiliary pathology, with over half a million procedures annually in the United States alone.[[1]] Pancreaticobiliary pathology is more common in the elderly, with an estimated 10–20% of elderly patients presenting with cholecystitis having coexisting choledocholithiasis, compared to 5% in the general population. In addition, the incidence of ductal stones in elderly patients undergoing emergency cholecystectomy approaches 50%.[[2,3]] Due to an ageing worldwide population, ERCP is increasingly utilised in the elderly as a therapeutic tool.[[3–6]] Despite this, ERCP in the elderly is purported to be associated with increased procedural difficulty and periprocedural adverse events. The increased risk might be expected due to a higher prevalence of frailty and comorbidities in this population, and the safety of ERCP in the elderly is often debated, with age frequently cited as a contraindication.[[7]]

Despite the perceived risks of ERCP in the elderly, there are limited comparative studies on outcomes. Literature on the safety and complication rates of older patients undergoing ERCP is conflicting. A systematic review of 18 studies by Harmeet et al. in 2017 concluded that ERCP was safe in the elderly, with higher rates of post-ERCP pancreatitis reported in younger patients.[[2,7]] Another study of octogenarians undergoing ERCP with a mean age of 84 years cited a mortality rate of 3.1%, which is considerably lower than the standard quoted mortality rate of 5%.[[3,8]] In contrast, high rates of post-ERCP mortality were reported by Kalaitzakis et al. in the very elderly >80 years, mainly due to underlying diseases, notably cancer.[[8]] Sedation for ERCP is also associated with increased risks in the elderly and may contribute to periprocedural morbidity and mortality.[[9]]

To our knowledge, there is no comparative outcomes data for elderly patients undergoing ERCP in New Zealand. Increased understanding of the complication and outcomes of ERCP could help clinicians select the best therapeutic approach and potentially avoid exposing vulnerable patients to risky interventions.

Methods

The records of 509 consecutive ERCP procedures performed between September 2019 and September 2020 were retrospectively reviewed. Procedural details were captured from endoscopy reports via ProVation® MD software. In addition, a comprehensive assessment of clinical records, including radiology and laboratory data, was completed. Specific data collected included demographics, procedural indication, American Society for Gastrointestinal Endoscopy (ASGE) complexity score,[[10,11]] procedural techniques and whether non-steroidal anti-inflammatories (NSAIDs) were prescribed. Comorbidities were classified using the Charlson Comorbidity Index (CCI) below. The cause of death was obtained via clinical records. Patients were divided into elderly >75 years and controls ≤75 years old for analysis and comparison. Ethics approval was obtained from the Health and Disability Ethics Committee.

All procedures were completed by four consultant gastroenterologists and a senior endoscopy fellow at Middlemore Hospital. Middlemore Hospital is a tertiary referral centre for Counties Manukau District Health Board in Auckland, New Zealand and services approximately 567,000 people, representing 11% of the total New Zealand population in 2018.[[12]] Both emergency and elective ERCP were included. The majority utilised conscious sedation with a combination of midazolam and fentanyl as directed by the endoscopist. A small number of procedures were conducted with propofol or general anaesthesia. Rectal NSAIDs with diclofenac were prescribed at the start of each procedure for post-ERCP pancreatitis (PEP) prophylaxis at the endoscopist’s discretion. Cannulation was typically carried out using a guidewire-assisted technique with a sphincterotome; other interventions such as needle-knife or trans-pancreatic precut sphincterotomy, dilatation and stenting were carried out depending on the requirements of each procedure and the endoscopist expertise.

Charlson Comorbidity Index

CCI is an internationally recognised method of categorising comorbidities based on the International Classification of Diseases. Comorbidities are weighted based on the adjusted risk of mortality or resource use at one year, and the sum of all the weights results in a single comorbidity score for each patient.[[13,14]] Nineteen conditions are used in the scoring system and given a weight based on the estimated mortality hazard ratio from a Cox proportional hazards model. A score of zero indicates no comorbidities, whilst a score of five or more may be considered highly comorbid. Studies have shown that using the CCI as a composite score is a better predictor of prognosis than individual comorbidities alone.[[14]]

Primary and secondary outcomes

The primary outcome was complications from ERCP based on clinical records, laboratory findings and radiology results. Pancreatitis was classified using the revised Atlanta classification for pancreatitis, which requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis; (b) serum amylase or lipase level greater than three times the upper normal value; or (c) characteristic imaging findings.[[15]] In addition, the Cotton criteria were used for grading bleeding, perforation and sepsis.[[10,16]] We also examined variables that predicted PEP in a multivariate analysis model.

Secondary outcomes were the length of hospital stay after complications from ERCP, intensive care admissions, and all-cause mortality at 30 and 90 days following ERCP.

Statistics

Our sample size was greater than the estimated sample size of 400 procedures required to detect a 10% difference between study groups for combined adverse events from ERCP (α 0.05; statistical power 80%; 1:3 enrolment ratio).

Fisher’s exact test was used for categorical variables, and the Mann–Whitney U test for non-categorical variables was performed to compare study groups. Statistical significance was set at the p value <0.05 (two-sided) level. Potential variables for ERCP complications were entered into a multivariate logistic regression analysis with odds ratio adjusted for potential confounders. Mortality results were presented using Kaplan–Meier survival curves. Data analysis was completed using IBM Statistics 26 program (SPSS Inc, Chicago, III).

Results

A total of 509 ERCP procedures performed on 338 patients were included. The mean age was 61 years (range 16–93). The elderly >75 years cohort comprised 23% (117/509) of the total procedures. Compared to the younger cohort, the elderly were more likely to be male (53.8% vs 39.8%; p=0.007) and of NZ European ethnicity (51.3% vs 35.2%; p=0.002). The elderly cohort also had a significantly higher CCI (mean 6.25 vs 3.17). There was no significant difference in ERCP indications and ASGE complexity score between the elderly and young groups. The most common indication for ERCP was choledocholithiasis (43%), ascending cholangitis (16.3%), pancreatic cancer (9.4%), gallstone pancreatitis (6.9%), biliary cancer (5.5%) and jaundice—cause not specified (5.5%). The elderly group were less likely to receive NSAIDs at ERCP (9.4% vs 19.3%; p=0.002). Other procedural characteristics were similar between groups (Table 1).

Complications from ERCP

Forty-four complications occurred in 42 (8%) patients, 11 (2%) of which were severe, including four deaths. Pancreatitis occurred in six (5.1%) patients of the elderly versus 27 (6.9%) patients in the younger cohort, with no statistical difference (p=0.669). In addition, there was no difference in the total number of complications, intensive care admissions and length of hospital stay after complications (median four days in elderly vs five days in the younger cohort; p=0.354) (see Table 2). Complication rates did not differ between senior endoscopists or in cases involving a fellow.

Predictors of PEP

Multivariate logistical regression showed that neither age >75 years nor CCI ≥5 was associated with an increased risk of PEP. After adjusting for other variables, an increased risk of PEP was observed in females (adjusted odds ratio AOR=2.93; 95% confidence interval (CI):1.12–7.67; p=0.028), pre-cut sphincterotomy (AOR=6.82; 95% CI:1.82–25.6; p=0.004) and pancreatic sphincterotomy (AOR=23.65; 95% CI: 3.74–149.7; p=0.001). Interestingly, ASGE complexity score was not associated with an increased risk of PEP; however, NSAID use was associated with PEP (AOR=4.28; 95% CI: 1.89–9.7; p=0.001) (see Table 3).

30- and 90-day all-cause mortality

At 30-days post ERCP, there were 22 deaths from any cause, representing 4.32% of the study population. Fifty deaths (9.8%) were observed at 90 days post ERCP. All-cause mortality was significantly higher in the elderly group at 30 days (8.5% vs 2%; p=0.002) and 90-days (19.7% vs 6.9%; p<0.001). Causes of death at 90 days are summarised in Figure 1.

After adjusting for sex and ethnicity, multivariate logistical regression showed that a CCI ≥5 significantly increased all-cause mortality at 90 days (AOR=74.44; 95% CI: 9.78–566.38; p<0.001), followed by malignant biliary disease (AOR=2.89; 95% CI: 1.44–5.79; p=0.003) and age >75 years (AOR=2.28; 95% CI: 1.14–4.55; p=0.02). Complications from ERCP did not significantly increase the odds of death at 90-days in our model (see Table 4). Considering patients in both groups, CCI ≥5 increased the odds of death at 90 days (see Figure 2).

View Tables 1–4 & Figures 1–2.

Discussion

Our finding is the first of its kind in New Zealand and adds to the growing literature on ERCP in the elderly. There was no difference in ERCP complication rates between the elderly and younger patients. This is consistent with an earlier systematic review that demonstrated incidence rates of ERCP complications for elderly patients similar to most reported literature.[[17]] While several studies have established the safety and efficacy of ERCP in the elderly, they had limitations with lacking a comparator group or including outcomes for elderly patients as young as 60 years old.[[18–20]]

Counter-intuitively, NSAID use was associated with increased pancreatitis in multivariate analysis. At the time of this study, NSAID use was at the endoscopist’s discretion and typically only for patients considered at high risk of PEP. The overall NSAID use was significantly lower in the elderly cohort, and this should increase the risk of pancreatitis in the elderly, but our findings show similar rates of pancreatitis versus the younger cohort. Advancing age has been shown to have a protective role against the development of PEP in prior studies and, perhaps, offset the effects of lower NSAID use amongst the elderly.[[2]]

While ERCP-related mortality is well-described, there is a lack of comparative data on all-cause mortality in the elderly and few studies that incorporate a standardised comorbidity index. We reported a 9.8% all-cause mortality at 90 days post ERCP, comparable to published data from international registries.[[8,21,22]] Mortality post ERCP was driven primarily by comorbidities, and a CCI of ≥5 was the strongest predictor of death. 90-day mortality was rarely observed in those with a CCI of <5, irrespective of age. We did not find an increased risk of ERCP complications in those with CCI ≥5, in contrast to a study of 614 patients where a CCI of ≥2 was recorded in 21% of the cohort and was associated with increased odds of adverse events from ERCP.[[23]] This is despite our cohort being more comorbid, with a CCI ≥5 recorded in 36.6%. Although CCI may have a role in risk stratification, we agree with Galeazzi et al. that a multidomain, comprehensive geriatric assessment should be considered to understand the patient beyond medical history or fitness level.[[24]]

A prior systematic review has demonstrated cardiopulmonary complications as the most common ERCP complication among nonagenarians.[[25]] Our study did not attribute deaths to cardiopulmonary complications; however, we collected data from hospital records and death certificates which may overlook short-term cardiopulmonary events. We should note that most procedures in our study were completed with conscious sedation utilising a combination of midazolam and fentanyl, which may differ from international literature where propofol or general anaesthesia may be employed more frequently. In one randomised study, propofol sedation was associated with a shorter recovery time and less hypoxic events among high-risk octogenarians undergoing ERCP.[[26]]

The main limitation of our study was the single-centre retrospective design. Future prospective studies would help explore the full spectrum of risks in the elderly, including cardiopulmonary adverse events. Due to a lack of a non-interventional control group, the clinical course of elderly patients not undergoing ERCP was not explored. While this may lead to selection bias, a randomised study of this nature is unlikely to happen as it would not be ethical to withhold critical ERCP routinely.

In conclusion, ERCP is relatively safe in elderly patients and should not be withheld based on age alone. The higher prevalence of comorbidities in the elderly should be considered to avoid subjecting vulnerable individuals with a short life expectancy to procedures where potential benefits outweigh the risk of harm.

Summary

Abstract

Aim

To ascertain if endoscopic retrograde cholangiopancreatography (ERCP) in the elderly is associated with an increased risk of complications.

Method

Retrospective study of 509 consecutive ERCPs on 338 patients in one year (2019–2020). Patients were categorised as >75 years old (elderly test group) or ≤75 (controls). The primary outcome was ERCP complications. Secondary outcomes were the length of hospital stay after complications, intensive care admissions, and all-cause mortality at 30 and 90 days.

Results

Forty-four complications occurred in a group of 42 (8%) patients; 11 (2%) were severe, including four deaths. The most common complication was pancreatitis n=33 (6%). There was no difference in complication rates between the elderly and younger controls. Length of stay after complications was similar (median five versus four days; p=0.354). All-cause mortality was higher in the elderly at 30-days (8.5% versus 2%; p=0.002) and 90-days (19.7% versus 6.9%; p=0.001), mostly attributed to malignancy. Logistic analysis showed that neither age >75 years nor Charlson Comorbidity Index (CCI) ≥5 was associated with post-ERCP pancreatitis, but a CCI≥5 strongly increased the odds of death at 90-days (AOR=74.44; 95% confidence interval (CI): 9.78- 566.38, p<0.001).

Conclusion

ERCP is relatively safe in elderly patients, but comorbidities should be considered to avoid subjecting vulnerable individuals with a short life expectancy to unnecessary procedures.

Author Information

Kirsty Macfarlane: Gastroenterology Fellow, Department of Gastroenterology, Auckland City Hospital, New Zealand. Reuben Wilson: Medical Registrar, Department of Medicine, Auckland City Hospital, New Zealand. Nicholas J Fischer, FRACS: Department of Hepatobiliary & Pancreatic Surgery. Royal Surrey County Hospital. United Kingdom. Henry Wei: Consultant Gastroenterologist, Department of Gastroenterology, Auckland City Hospital, New Zealand; Faculty of Medicine, University of Auckland, New Zealand.

Acknowledgements

We are grateful to the outstanding endoscopy team at Middlemore Hospital for their assistance and data collection during these procedures.

Correspondence

Dr Henry Wei: C/O Department of Gastroenterology, Level 6 support building, Auckland City Hospital, 2 Park Road, Grafton, New Zealand.

Correspondence Email

Henry.Wei@adhb.govt.nz

Competing Interests

Nil.

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