Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis

Not Applicable

Recruiting

• Conditions: Post-ERCP Pancreatitis
• Interventions: Drug: low dose indomethacin; Drug: standard dose indomethacin

• Registration Number: NCT07088757
• Lead Sponsor: Changhai Hospital

Brief Summary

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP.

Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks.

This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation.

The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-19
• Study First Submitted QC: 2025-07-19
• Study First Posted: 2025-07-28
• Status Verified: 2025-09
• Study Start: 2025-09-15
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1366

Inclusion Criteria

• Adults aged 18 years or older.
• Patients planned to undergo Endoscopic Retrograde Cholangiopancreatography

Exclusion Criteria

• Standard contraindications to ERCP
• Allergy to Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• Use of NSAIDs within 7 days prior to ERCP
• Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
• Acute pancreatitis within 3 days before ERCP
• Hemodynamic instability
• Pregnancy or lactation
• Patients who are unwilling or unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose indomethacin	low dose indomethacin	patients randomized to this intervention receive 50mg indomethacin
standard dose indomethacin	standard dose indomethacin	patients randomized to this intervention receive 100mg indomethacin

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis	Within 48 hours after ERCP

Secondary Outcome Measures

Name	Time	Method
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis	Within one month of ERCP
Rate of Overall ERCP-related complications	Within one month of ERCP	ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Rate of ERCP-related perforation	Within one month of ERCP
Rate of ERCP-related infection	Within one month of ERCP
Rate of ERCP-related bleeding	Within one month of ERCP
Rate of NSAIDs-related complications	Within one month of ERCP	NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death

Trial Locations

Locations (12)

Changhai Hospital; 🇨🇳 Shanghai, China

Ruijin Hospital; 🇨🇳 Shanghai, China

Shanghai General Hospital; 🇨🇳 Shanghai, China

Affiliated Hospital of Jiaxing University; 🇨🇳 Zhejiang, China

Dongyang People's Hospital; 🇨🇳 Zhejiang, China

First Affiliated Hospital of Ningbo University; 🇨🇳 Zhejiang, China

Jinhua Central Hospital; 🇨🇳 Zhejiang, China

People's Hospital of Quzhou; 🇨🇳 Zhejiang, China

Shaoxing People's Hospital; 🇨🇳 Zhejiang, China

Sir Run Run Shaw Hospital; 🇨🇳 Zhejiang, China

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