Factors for Prolonged Hospital Stays in Patients Undergoing ERCP

Factors Associated With Prolonged Hospital Stay in Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective, Multicenter Cohort Study

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, we 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.

Study Overview

• Status: Recruiting
• Conditions: Post-ERCP Adverse Events; ERCP Complications

• Study Type: Observational
• Enrollment (Estimated): 504

Contacts and Locations

• Study Contact: Name: Yanglin Pan, M.D; Phone Number: 13991811225; Email: yanglinpan@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Xijing Hospital of Digestive Diseases
      • Contact: Yanglin Pan, M.D; Phone Number: 13991811225; Email: yanglinpan@hotmail.com
    • Xi'an, Shaanxi, China, 710054
      • Recruiting
      • Department of Gastroenterology, 986 Hospital of Xijing Hospital, Fourth MilitaryMedical University
      • Contact: Jun Wang, M.D; Phone Number: 86-29-84734201; Email: Wangjundoctor@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥ 65 years old who are scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) are eligible for our study.

Description

Inclusion Criteria:

1. Patient age ≥ 65 years
2. Scheduled to undergo ERCP procedure

Exclusion Criteria:

1. Severe cognitive dysfunction
2. Severe hearing impairment
3. Known or suspected gastrointestinal perforation
4. Hemodynamic instability
5. Pregnant or lactating women
6. Unable to sign the informed consent form

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of total adverse events	Adverse events include ERCP-related or non ERCP-related adverse events	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.	30 days
Post-procedure Length of Hospital Stay	The number of days from the day of the ERCP procedure to hospital discharge	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.	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.	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.	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.	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.	30 days

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; ERCP; Adverse Events; Length of Stay
• Other Study ID Numbers: KY20252608-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No