Indomethacin vs diclofenac to prevent pancreatitis after ERCP

Rectal Indomethacin Versus Diclofenac for Prevention of Post-ERCP Panceratitis (IDPPP2): A Multicenter, Double-blind, Randomized, Control Trial

This trial tests whether a single 100 mg rectal dose of indomethacin or diclofenac given before ERCP better prevents post-ERCP pancreatitis in adults with a native papilla.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4050 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Air Force Military Medical University, China (Academic / other)
• Locations: 20 sites (Beijing, Beijing Municipality and 19 other locations)
• Trial ID: NCT07071441 on ClinicalTrials.gov

What this trial studies

Adults aged 18–90 with a native papilla scheduled for ERCP are randomized to receive either 100 mg rectal indomethacin or 100 mg rectal diclofenac before the procedure. Key exclusions include recent NSAID use, planned pancreatic duct stenting, recent acute pancreatitis, significant bleeding risk or renal dysfunction, pregnancy, and inability to consent. The trial measures the incidence of post-ERCP pancreatitis and monitors NSAID-related adverse events. It is a multicenter head-to-head comparison conducted at tertiary hospitals in China.

Who should consider this trial

Good fit: Adults 18–90 years old with a native papilla undergoing ERCP who have no contraindications to NSAIDs are ideal candidates.

Not a fit: Patients who cannot receive NSAIDs (recent GI bleeding, significant renal dysfunction, coagulopathy, pregnancy, or recent NSAID use) or those planned for pancreatic stenting are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the trial could identify which NSAID more effectively lowers the risk of post-ERCP pancreatitis, helping clinicians choose the better preventive option.

How similar studies have performed: Prior meta-analyses found 100 mg rectal indomethacin and diclofenac each reduce PEP risk and a recent meta-analysis suggested diclofenac may be more effective, but direct randomized head-to-head data remain limited.

Eligibility criteria

Inclusion Criteria:

* 18-90 years old patients with native papilla who planned to undergo ERCP

Exclusion Criteria:

* Previous biliary sphincterotomy and papillary large balloon dilation
* Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)
* Allergy to NSAIDs
* The administration of NSAIDs within 7 days
* 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 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections
* Hemodynamical instability
* Pregnancy or lactation
* Unable to give informed consent

Where this trial is running

Beijing, Beijing Municipality and 19 other locations

• The first medical center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• Department of Gastroenterology, Hongai Hospital — Xiamen, Fujian, China (Recruiting)
• Harbin Medical University Affiliated Fourth Hospital — Harbin, Heilongjiang, China (Recruiting)
• [e-mail] — Harbin, Heilongjiang, China (Recruiting)
• Huaihe Hospital of Henan University — Kaifeng, Hennan, China (Recruiting)
• Renmin hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Jilin Miniciple People'S Hospital — Jilin, Jilin, China (Recruiting)
• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Not_yet_recruiting)
• 986 Hospital of Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
• Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
• Xijing Hospital of Digestive Diseases — Xi'an, Shaanxi, China (Recruiting)
• Shandong Provincial Third Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• The 960th Hospital of the PLA — Jinan, Shandong, China (Recruiting)
• Eastern Hepatobiliary Surgery Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Affiliated Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• the First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• the second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yanglin Pan, MD

Conditions ERCP; Pancreatitis; Non-steroidal Anti-inflammatory; Indomethacin; Diclofenac