Menu
Recruiting NCT07568626

Factors for Prolonged Hospital Stays in Patients Undergoing ERCP

Observational Post-ERCP Adverse Events ERCP Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post-ERCP Adverse Events, ERCP Complications. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Prolonged Postoperative Length of Stay [Time frame: 30 days]
Secondary outcome measures (8)
  • Rate of total adverse events [Time frame: 30 days]
  • Total Length of Hospital Stay [Time frame: 30 days]
  • Post-procedure Length of Hospital Stay [Time frame: 30 days]
  • Rate of post-ERCP Pancreatitis [Time frame: 30 days]
  • Rate of ERCP-related bleeding [Time frame: 30 days]
  • Rate of ERCP-related perforation [Time frame: 30 days]
  • Rate of ERCP-related infection [Time frame: 30 days]
  • Total Hospitalization Costs [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • Xiamen Hong'ai Hospital — Xiamen
  • Xijing Hospital of Digestive Diseases — Xi'an
  • The Second Affiliated Hospital of Air Force Military Medical University — Xi'an
  • Department of Gastroenterology, 986 Hospital of Xijing Hospital, Fourth MilitaryMedical Un — Xi'an
  • Xi'an Honghui Hospital — Xi'an

Identifiers

NCT: NCT07568626 · KY20252608-C-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗