Low-dose versus standard-dose indomethacin to prevent pancreatitis after ERCP

Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial

This test sees if a lower rectal dose of indomethacin prevents pancreatitis as well as the standard 100 mg dose in adults undergoing ERCP.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1366 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 12 sites (Shanghai and 11 other locations)
• Trial ID: NCT07088757 on ClinicalTrials.gov

What this trial studies

This multicenter, interventional Phase 4 study compares a lower dose of rectal indomethacin with the standard 100 mg dose given before ERCP to prevent post-ERCP pancreatitis (PEP). Adult patients scheduled for ERCP at participating Shanghai hospitals will receive either the low-dose or standard-dose indomethacin prior to the procedure. Key outcomes include the incidence of PEP and rates of NSAID-related adverse events such as gastrointestinal bleeding and renal impairment. Patients with NSAID contraindications, recent NSAID use, active GI bleeding, significant renal dysfunction, pregnancy, or recent acute pancreatitis are excluded.

Who should consider this trial

Good fit: Adults aged 18 or older who are scheduled to undergo ERCP and who have no contraindications to NSAIDs are ideal candidates.

Not a fit: People with NSAID allergy or contraindications (recent GI hemorrhage, significant renal dysfunction, pregnancy), recent NSAID use, or active acute pancreatitis are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the study could allow use of a lower indomethacin dose that still prevents PEP while reducing NSAID-related side effects.

How similar studies have performed: Prior trials and guidelines have shown that 100 mg rectal indomethacin reduces PEP, but lower-dose regimens have been less well studied.

Eligibility criteria

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

Where this trial is running

Shanghai and 11 other locations

• Changhai Hospital — Shanghai, China (Not_yet_recruiting)
• Ruijin Hospital — Shanghai, China (Recruiting)
• Shanghai General Hospital — Shanghai, China (Not_yet_recruiting)
• Affiliated Hospital of Jiaxing University — Zhejiang, China (Not_yet_recruiting)
• Dongyang People's Hospital — Zhejiang, China (Not_yet_recruiting)
• First Affiliated Hospital of Ningbo University — Zhejiang, China (Not_yet_recruiting)
• Jinhua Central Hospital — Zhejiang, China (Not_yet_recruiting)
• People's Hospital of Quzhou — Zhejiang, China (Not_yet_recruiting)
• Shaoxing People's Hospital — Zhejiang, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital — Zhejiang, China (Recruiting)
• Taizhou Enze Medical Center Group — Zhejiang, China (Recruiting)
• Zhuji People's Hospital of Zhejiang Province — Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Liang-Hao Hu

Conditions Post-ERCP Pancreatitis