Factors for Prolonged Hospital Stays in Patients Undergoing ERCP

NCT07568626 | Recruiting DMC

• 1 other identifier: KY20252608-C-1
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post-ERCP Adverse Events; ERCP Complications

Keywords

Elderly; Length of Stay; Adverse Events; ERCP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Rate of total adverse events

  30 days

• Total Length of Hospital Stay

  30 days

• Post-procedure Length of Hospital Stay

  30 days

• Rate of post-ERCP Pancreatitis

  30 days

• Rate of ERCP-related bleeding

  30 days

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Patient age ≥ 65 years
• Scheduled to undergo ERCP procedure

You may not qualify if:

• Severe cognitive dysfunction
• Severe hearing impairment
• Known or suspected gastrointestinal perforation
• Hemodynamic instability
• Pregnant or lactating women
• Unable to sign the informed consent form

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (2)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710000, China

RECRUITING

Department of Gastroenterology, 986 Hospital of Xijing Hospital, Fourth MilitaryMedical University

Xi'an, Shaanxi, 710054, China

RECRUITING

Central Study Contacts

Yanglin Pan, M.D

CONTACT

13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CN (2)