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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 4050 (estimated) |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Locations | 20 sites (Beijing, Beijing Municipality and 19 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07071441 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
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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
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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
- Study coordinator: Yanglin Pan, MD
- Email: yanglinpan@hotmail.com
- Phone: 86-84771536
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Short-stay aggressive hydration to prevent post-ERCP pancreatitis
This trial tests whether a short, high-volume IV hydration with Lactated Ringer's plus a rectal indomethacin can prevent post-ERCP pancreatitis in adults undergoing ERCP.
-
Biomechanical Factors During ERCP for Digestive Specialists
This study tests how ERCP practitioners experience biomechanical stress during the procedure to see if adjustments to equipment or setup can reduce strain.
-
Phosphate therapy for adults with acute pancreatitis
This study tests whether giving phosphate through an IV can help adults with acute pancreatitis treated in the emergency department.
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Cold water rinse plus rectal indomethacin to prevent pancreatitis after ERCP
This will test whether rinsing the papilla with cold water plus a rectal indomethacin dose lowers the chance of pancreatitis for adults undergoing ERCP.
-
Preventing complications after high-risk Whipple (pancreatoduodenectomy) with hydrocortisone, octreotide, and a teres ligament patch
This tests whether giving hydrocortisone and octreotide around surgery plus placing a teres ligament patch can lower major complications after Whipple surgery in patients with a small pancreatic duct.
-
Scrambler therapy for chronic pancreatitis pain
We will test whether Scrambler Therapy can reduce persistent abdominal pain in adults with chronic pancreatitis who haven't found relief from standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.