Clinical trial Recruiting at 16 sites Interventional Ages 18 to 90

Indomethacin vs diclofenac to prevent pancreatitis after ERCP

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

Run by Air Force Military Medical University, China · NCT07071441 · Data updated 2026-11-12

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.

More Pancreatitis trials

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment4050 (estimated)
SponsorAir Force Military Medical University, China
Academic / other
Locations20 sites (Beijing, Beijing Municipality and 19 other locations)
StatusRecruiting
StartedJune 1, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 15, 2026
Trial IDNCT07071441 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Zhaolei181220@163.Com
    Harbin, Heilongjiang, China
    Recruiting
  • Huaihe Hospital of Henan University
    Kaifeng, Hennan, China
    Recruiting
Show 14 more locations
  • Renmin hospital of Wuhan University
    Wuhan, Hubei, China
    Recruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
  • Jilin Miniciple People'S Hospital
    Jilin City, Jilin, China
    Recruiting
  • Qinghai University Affiliated Hospital
    Xining, Qinghai, China
    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
  • The 960th Hospital of the PLA
    Jinan, Shandong, China
    Recruiting
  • Eastern Hepatobiliary Surgery Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting
  • the First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan, China
    Not yet recruiting
  • Shandong Provincial Third Hospital
    Jinan, Shandong, China
    Not yet recruiting
  • Affiliated Hangzhou First People's Hospital
    Hangzhou, Zhejiang, China
    Not yet recruiting
  • the second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.