Literature on the safety of endoscopic retrograde cholangiopancreatography (ERCP) in elderly patients is divided. Based on this we decided to examine the safety of ERCP in nonagenarian patients.
A total of 1,389 patients, with a mean age of 63.94±19.62 years, underwent ERCP during the study period. There were 74 patients aged 90 years or older with a mean age of 92.07±1.8. Logistic regression showed that nonagenarian patients had a significantly increased odds of in-patient mortality (adjusted odds ratio [AOR]=9.6; 95% confidence interval [CI]=4, 23;
Age ≥90 and CCI ≥2 are independently associated with increased odds of in-patient mortality in patients undergoing ERCP, whereas emergency procedures and CCI ≥2 are associated with an increased adverse event rate. Caution must be exercised when considering ERCP in patients aged ≥90 years and those with a CCI ≥2.
As the average life expectancy in the United States continues to rise [
Extrapolating from this data, ERCPs are being performed on increasingly older patients with little data regarding their safety in geriatric populations. Limited by small patient pools, data on the safety of ERCP in elderly patients is divided. Based on this we decided to evaluate the safety of ERCP in nonagenarian patients at our institution.
After approval by the institutional review board, a retrospective chart review of patients undergoing ERCP at our institution was carried out. All patients undergoing primary diagnostic/therapeutic ERCP between January 1, 2012 and December 31, 2016 were abstracted. Patients undergoing follow-up ERCP for stent removal were excluded. The patients were divided into two groups based on their age (group 1 included patients aged 90 years and above; and group 2 included those aged between 18 and 89 years). The charts were reviewed for the presence of comorbidities, indications, procedure time, adverse events, and outcomes. Comorbidities were weighted using the Charlson Comorbidity Index (CCI). An arbitrary cutoff of CCI ≥2 was used to stratify the patients based on their comorbidities.
Indications were grouped into biliary stone disease (including choledocholithiasis and biliary pancreatitis), cholangitis, and abnormal imaging/tumors (including patients with known or suspected malignancy). Adverse events were grouped into major and minor. Major adverse events included bleeding requiring blood transfusions or interventions, mucosal injuries, perforations, cardio-pulmonary events, and procedure-related mortality. Minor adverse events included minor post-procedural bleeding evidenced by a drop in hemoglobin (not requiring transfusion or intervention), post-ERCP pancreatitis, or fevers. Self-limited post-sphincterotomy bleeding observed during the procedure, without a drop in post-procedure hemoglobin, was not considered as an adverse event. All major and minor adverse events were grouped together into a binary (yes/no) variable for analysis. While most studies on the topic considered procedure-related mortality as one of their outcome variables, we considered all-cause in-patient mortality during the index hospitalization as our outcome.
Descriptive analysis was performed by medians and interquartile ranges (IQRs) for continuous variables, as they were not normally distributed. Pearson’s chi-squared, Fisher’s exact, and Mann–Whitney
A total of 1,389 patients, with a median age of 67 (IQR 52, 80) underwent primary ERCP at our center during the study period. The patients were predominantly female (59.4%,
There were 74 patients (5.3%) aged 90 years or older with a median age of 92 (IQR 90.75, 93) in group 1 compared to 1,315 patients (94.7%) with a median age of 65 (IQR 50, 78) in group 2. Group 1 had more female patients compared to group 2 (73% vs. 58.6%,
Both groups had an equal proportion of patients with a CCI ≥2 (29.7% vs. 27.9%,
A multivariate model, taking into account emergency procedures, age, CCI ≥2, and indications, was created. For indications, biliary stone disease was considered as the reference constant. Logistic regression showed that age ≥90 was not associated with increased adverse events, however emergency procedures (adjusted odds ratio [AOR]=2.45; 95% confidence interval [CI]=1.49, 4.03;
Patients in group 1 (nonagenarians) had significantly increased odds of in-patient mortality (AOR=9.5; 95% CI=4, 22.98;
As average life expectancy continues to increase worldwide, medical professionals are faced with an increasingly older population requiring invasive procedures. The care of geriatric patients is complicated by overall frailty, in addition to a host of comorbidities and polypharmacy as a result of these comorbid conditions. As discussed earlier, invasive procedures are frequently carried out on geriatric patients with limited population-specific safety data. Although multiple studies on the safety of ERCPs in octogenarians and nonagenarians have been published, the data available does not provide conclusive evidence due to small sample sizes and a lack of control groups (
Our study evaluated 1,389 patients undergoing ERCP at a single center over a period of 5 years. During this period, 74 patients (5.3%) were aged 90 years or older at the time of the procedure. We excluded patients undergoing ERCP for stent removal from our sample considering the different nature of the procedure. Although comorbidities were differently distributed between the two groups (
Biliary stones were the predominant indication for the procedure in both groups. Group 2 had an increased proportion of patients undergoing ERCP due to abnormal radiological findings and tumors compared to the older population, which had a higher proportion of patients with cholangitis. Although speculative, this finding may represent a tendency toward less aggressive care in elderly patients rather than a decreased incidence of tumors and abnormal radiological findings. There was no difference in the procedural success rates between the 2 groups.
We did not find any increase in the odds of adverse events in the patients aged ≥90 years when compared to younger patients on univariate and multivariate analyses. However, an increased odds of adverse events was noted with emergency procedures (AOR=2.45) and a CCI ≥2 (AOR=2.58). These findings were comparable to other studies reported in literature.
Finkelmeier et al. noted that although the rate of procedure-related mortality was comparable between older (aged 80 years or older) and younger patients, the rate of sedation-related adverse events was higher in the older population [
Most studies have reported no significant differences in procedure-related mortality rates between younger and older populations. We did not have any procedure-related deaths in our sample. From a patient stand-point, we considered all-cause in-patient mortality during the index admission as our primary outcome and found a significantly increased all-cause in-patient mortality in patients aged 90 years and above (12.2% vs. 1.6%, AOR 9.6). Mitchell et al., with a sample of 23 patients aged 90 years and above, reported a comparable all-cause in-patient mortality rate of 13%, and Grönroos et al. reported an “early mortality” rate of 10% [
Hui et al. reported a 30-day mortality in patients undergoing emergency ERCPs for cholangitis and did not find any significant difference between nonagenarians and the younger population (7.8% vs. 4.2%,
Although one can argue that the all-cause in-patient mortality was not directly attributable to the procedure itself but rather to the patients’ pathology, we recommend that ERCPs be approached with caution in nonagenarian patients and those with a CCI ≥2.
The analyses were limited by the small sample size, particularly as it obtained from one site. Considering the sample size and rarity of certain adverse events and outcomes, and demographic variability, we were unable to tease out many covariates. That being said, our sample size of patients aged 90 and above was among the largest studies of its type.
Summary of Patient Demographics with Distribution of Comorbidities, Indications, and Individual Adverse Events
Overall ( |
Age ≥90 ( |
Age <90 ( |
||
---|---|---|---|---|
Age, median (IQR) | 67.0 (52, 80) | 92 (91, 93) | 65 (50, 78) | |
Charlson score, median (IQR) | 1.0 (0.0, 2.0) | 1.0 (0.0, 2.0) | 0.0 (0.0, 2.0) | 0.09 |
Charlson score ≥2, % (n) | 28.0% (389) | 29.7% (22) | 27.9% (367) | 0.73 |
Procedure time in minutes median (IQR) |
33:00 (22:06, 50:27) | 33:00 (22:00, 50:27) | 33:00 (24:00, 50:48) | 0.76 |
Male, % (n) | 40.6% (564) | 27.0% (20) | 41.4% (544) | 0.02 |
Emergency, % (n) | 15.4% (214) | 9.5% (7) | 15.7% (207) | 0.15 |
Success rate, % (n) | 89.4% (1242) | 89.2% (66) | 89.4% (1176) | 0.95 |
Periampullary diverticulum, % (n) | 11.5% (160) | 28.4% (21) | 10.6% (139) | <0.001 |
Sphincterotomy, % (n) | 58.5% (813) | 68.9% (51) | 57.9% (762) | 0.06 |
Rectal indomethacin, % (n) | 27.3% (379) | 28.4% (21) | 27.2% (358) | 0.83 |
Stent placement, % (n) | 73.5% (1020) | 74.3% (55) | 73.4% (965) | 0.87 |
Ethnicity |
||||
Caucasian (not Jewish or Hispanic) | 34.8% (484) | 36.5% (27) | 34.8% (457) | |
Jewish | 27.6% (383) | 51.4% (38) | 26.2% (345) | |
African American | 5.3% (73) | 1.4% (1) | 5.5% (72) | |
Asian | 19.8% (275) | 10.8% (8) | 20.3% (267) | |
South Asian | 1.4% (20) | - | 1.5% (20) | |
Hispanic | 3.3% (46) | - | 3.5% (46) | |
Native American | 0.8% (11) | - | 0.8% (11) | |
Middle Eastern | 4.1% (57) | - | 4.3% (57) | |
Other/No response | 2.8% (40) | - | 3.0% (40) | |
Comorbidities | ||||
Coronary artery disease | 6.7% (93) | 6.8% (5) | 6.7% (88) | 1 |
Congestive heart failure | 5.8% (81) | 18.9% (14) | 5.1% (67) | <0.001 |
Chronic obstructive pulmonary disease | 3.7% (51) | 8.1% (6) | 3.4% (45) | 0.05 |
Chronic kidney disease | 3.0% (41) | 8.1% (6) | 2.7% (35) | 0.019 |
Cerebrovascular accident | 3.2% (45) | 8.1% (6) | 3.0% (39) | 0.029 |
Diabetes mellitus | 25% (347) | 20.3% (15) | 25.2% (332) | 0.336 |
Hypertension | 50.6% (703) | 73.0% (54) | 49.4% (649) | <0.001 |
Peripheral vascular disease | 1.2% (17) | 4.1% (3) | 1.1% (14) | 0.058 |
Dementia | 2.7% (37) | 16.2% (12) | 1.9% (25) | <0.001 |
Peptic ulcer disease | 4.2% (58) | 5.4% (4) | 4.1% (54) | 0.546 |
Indications | ||||
Biliary stones | 50.9% (707) | 60.8% (45) | 50.3% (662) | 0.004 |
Cholangitis | 17.0% (236) | 24.3% (18) | 16.6% (218) | 0.004 |
Abnormal imaging/mass | 32.1% (446) | 14.9% (11) | 33.1% (435) | 0.004 |
Outcomes | ||||
In-patient mortality, % (n) | 2.2% (30) | 12.2% (9) | 1.6% (21) | <0.001 |
Overall adverse event rate | 7.0% (97) | 4.1% (3) | 7.1% (94) | 0.31 |
Individual adverse events |
||||
Minor adverse event rate | 5.0% (69) | 4.1% (3) | 5.0% (66) | |
Major adverse event rate | 2.0% (28) | - | 2.1% (28) | |
Minor bleeding | 1.2% (16) | 1.4% (1) | 1.1% (15) | |
Fever | 1.7% (23) | 1.4% (1) | 1.7% (22) | |
Post-ERCP pancreatitis | 2.2% (30) | 1.4% (1) | 2.2% (29) | |
Mucosal injuries | 0.1% (1) | - | 0.1% (1) | |
Bleeding requiring transfusion | 1.2% (16) | - | 1.2% (16) | |
Bleeding requiring intervention | 0.6% (8) | - | 0.6% (8) | |
Perforation | 0.2% (3) | - | 0.2% (3) |
IQR, interquartile range; ERCP, endoscopic retrograde cholangiopancreatography.
Independent sample Mann–Whitney
Pearson chi-squared test.
Fisher’s exact test.
Cell sizes are too small for analyses.
Summary of Multivariate Analysis Taking into Account Emergency Procedures, Age, CCI ≥2, and Indications
Adjusted odds ratio | 95% Confidence interval |
|||
---|---|---|---|---|
Lower | Upper | |||
Adverse events | ||||
Emergency procedure | 2.45 | 1.49 | 4.03 | <0.001 |
CCI ≥2 | 2.58 | 1.66 | 4.00 | <0.001 |
Age ≥90 | 0.52 | 0.16 | 1.70 | 0.28 |
Cholangitis |
0.49 | 0.27 | 0.91 | 0.02 |
Abnormal imaging/mass |
0.35 | 0.20 | 0.62 | 0.35 |
Mortality | ||||
Emergency procedure | 0.72 | 0.23 | 2.23 | 0.57 |
CCI ≥2 | 2.44 | 1.15 | 5.20 | 0.02 |
Age ≥90 | 9.58 | 4.00 | 22.98 | <0.001 |
Cholangitis |
3.98 | 1.42 | 11.20 | 0.01 |
Abnormal imaging/mass |
3.26 | 1.23 | 8.62 | 0.02 |
CCI, Charlson comorbidity index.
Biliary stone disease was considered as the reference constant.
Summary of Results from Studies Evaluating the Adverse Events of ERCP in Nonagenarian Patients
Year | Region | No. of procedures/patients |
Success rate |
Adverse event rate |
Mortality rate |
|||||
---|---|---|---|---|---|---|---|---|---|---|
≥90 | <90 | ≥90 | <90 | ≥90 | <90 | ≥90 | <90 | |||
Sugiyama et al. [ |
2000 | Japan | 22 | 381 | 100.0% | 98.4% | 4.5% | 6.8% | 0% | 0.3% |
Rodríguez-González et al. [ |
2003 | Spain | 126 | - | 90.5% | - | 2.5% | - | 0.7% | - |
Mitchell et al. [ |
2003 | Ireland | 23 | - | 91.3% | - | 13.0% | - | 13% |
- |
Hui et al. [ |
2004 | Hong Kong | 64 | 165 | 98.4% | 92.7% | 4.7% | 7.3% | 7.8% |
4.2% |
Huguet et al. [ |
2005 | Spain | 42 | - | 85.7% | - | 14.4% | - | 0% | - |
Katsinelos et al. [ |
2006 | Greece | 63 | 350 | 98.4% | 99.1% | 6.3% | 8.4% | 1.6% | 0.6% |
Cariani et al. [ |
2006 | Italy | 40 | - | 82.0% | - | 0.0% | - | 0% | - |
Grönroos et al. [ |
2010 | Finland | 41 | - | - | - | 7.0% | - | 10% |
|
Hu et al. [ |
2014 | China | 78 | 312 | 91.0% | 96.2% | 7.7% | 7.4% | - | - |
Yun et al. [ |
2014 | Korea | 43 | 129 | 86.0% | 94.0% | 12.0% | 22.0% | 2% | 0% |
This study | US | 74 | 1,315 | 89.2% | 89.4% | 4.1% | 7.1% | 12.2% |
1.6% |
ERCP, endoscopic retrograde cholangiopancreatography.
All-cause in-patient mortality.
Thirty-day mortality.
All patients underwent the procedure for cholangitis.
Early mortality, unclear definition.