About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age ≥ 65 years
Scheduled to undergo ERCP procedure
Disqualifiers
Severe cognitive dysfunction
Severe hearing impairment
Known or suspected gastrointestinal perforation
Hemodynamic instability
Trial population
Patients aged ≥ 65 years old who are scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) are eligible for our study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Rate of total adverse events
Adverse events include ERCP-related or non ERCP-related adverse events
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.
Post-procedure Length of Hospital Stay
The number of days from the day of the ERCP procedure to hospital discharge
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.
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