An observational study in Post-ERCP Adverse Events and ERCP Complications, sponsored by Air Force Military Medical University, China. Recruiting at 5 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Air Force Military Medical University, China · Observational
Endoscopic retrograde cholangiopancreatography (ERCP) is a crucial minimally invasive technique for the diagnosis and treatment of biliary and pancreatic diseases. However, it remains technically demanding and carries a postoperative adverse event (AE) rate exceeding 10% (e.g., pancreatitis, bleeding, and perforation), which subsequently leads to prolonged length of stay (LOS) and increased healthcare costs. With the rapid acceleration of population aging, the clinical demand for ERCP among the elderly has surged. Although ERCP is generally considered safe for older adults, advanced age also increases the risk of ERCP-related AEs and prolonged LOS. While previous studies investigated the outcomes of ERCP in elderly patients, those studies were predominantly retrospective, accompanied by selection bias. Moreover, insufficient factors were included in those retrospective studies. Importantly, some aging-related parameters, such as frailty, functional reserve, cognitive and psychological status, were not included in previous studies. Therefore, the investigators conducted a prospective, multicenter cohort study aimed at investigating outcomes in elderly patients undergoing ERCP and comprehensive factors (patient-related, procedure-related, and geriatric factors) associated with adverse outcomes.
Patients aged ≥ 65 years old who are scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) are eligible for our study.
Exclusion Criteria:
Prolonged Postoperative Length of Stay
A binary outcome defined as a postoperative length of stay \> 5 days. It is calculated as the duration from the completion of the ERCP procedure to the date of formal hospital discharge.
Time frame: 30 days
Rate of total adverse events
Adverse events include ERCP-related or non ERCP-related adverse events
Time frame: 30 days
Total Length of Hospital Stay
Total length of stay (TLOS), defined as the total duration in days from the date of hospital admission to the date of hospital discharge.
Time frame: 30 days
Post-procedure Length of Hospital Stay
The number of days from the day of the ERCP procedure to hospital discharge
Time frame: 30 days
Rate of post-ERCP Pancreatitis
a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus.
Time frame: 30 days
Rate of ERCP-related bleeding
Bleeding was established according to Cotton criteria. Mild: a documented decrease in hemoglobin concentration by \<3 g/L, without requiring the blood transfusion; Moderate: blood transfusion ≤ 4 units; without need for angiographic or surgery interventions ;Severe: Transfusion: ≥ 5 units or requiring for angiographic or surgery interventions.
Time frame: 30 days
Rate of ERCP-related perforation
Perforation was established according to Cotton criteria.Mild: slight leakage of fluid or contrast dye, manageable through fluid administration and suction therapy 3 days; Moderate: definite perforation required to be managed for 4-10 days; Severe: management for more than 10 days or requiring for percutaneous or surgical intervention.
Time frame: 30 days
Rate of ERCP-related infection
Infection was established according to Cotton criteria.Mild: temperature \>38℃ for 24-48h; Moderate: Febrile illness requiring \>3 days of hospital treatment; endoscopic or percutaneous interventions; Severe: septic shock or requiring surgery.
Time frame: 30 days
Total Hospitalization Costs
The sum of all medical expenses incurred during the entire hospitalization, denominated in Chinese Yuan (CNY). This includes costs for medication, laboratory and imaging tests, treatments, procedures, surgical operations, medical supplies, and bed occupancy.
Time frame: 30 days
Plan to share: Undecided
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Air Force Military Medical University, China