Factors for Prolonged Hospital Stays in Patients Undergoing ERCP

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAir Force Military Medical University, China

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
30 days

Secondary outcomes

1

Rate of total adverse events

Adverse events include ERCP-related or non ERCP-related adverse events

Time frame
30 days
2

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
3

Post-procedure Length of Hospital Stay

The number of days from the day of the ERCP procedure to hospital discharge

Time frame
30 days
4

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

Other outcomes

Sponsors and contacts

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