Indomethacin vs Diclofenac for Preventing PEP
Recruiting now · Not applicable
Conditions studied: ERCP, Pancreatitis, Non-steroidal Anti-inflammatory (NSAID), Indomethacin, Diclofenac
In brief
Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Preprocedural administration of rectal non-steroidal anti-inflammatory drugs (NSAIDs) was demonstrated to be an effective and convenient strategy for post-ERCP pancreatitis (PEP). Furthermore, several meta-analyses found that only 100mg indomethacin and diclofenac could effectively reduce PEP. Therefore, updated international clinical practice guidelines uniformly recommended administration of 100mg indomethacin or diclofenac in patients without contradictions. However, it was unclear which one of the two drug is more superior. A recent meta-analysis suggested 100mg rectal diclofenac was more efficacious than same-dose rectal indomethacin in PEP prevention (relative risk (RR) 0·59, 95% confidence intervals (CI) 0·40-0·89). Based on the results, we conducted a multicenter, double-blind, control trial to investigate whether 100mg diclofenac is superior than same-dose indomethacin. This trial planned to enroll 3612 patients in total. However, in the first interim analysis, PEP occurred in 53 patients (8.8%) of 600 patients allocated to diclofenac group and 37 patients (6.1%) of 604 patients allocated to indomethacin group (relative risk (RR) 1.44; 95% confidence interval (CI) 0.96-2.16, p=0.074). Thus, the trial was stopped according to the futility rule of conditional power. However, it was worth noticing that PEP tended to be higher in diclofenac group than that in indomethacin group. A sample size of 1204 was under power to draw the conclusion of significantly lower PEP rate in indomethacin group and thus a new trial with larger sample size of sufficient power is predicted to prove the superiority of indomethacin over diclofenac. Here we conducted a multicenter, randomized, double-blind trial to investigate whether 100mg indomethacin is superior to 100mg diclofenac in preventing PEP.
Key facts
- Study ID
- NCT07071441
- Run by
- Air Force Military Medical University, China
- People needed
- 4050
- Starts
- 2025-06-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-90 years old patients with native papilla who planned to undergo ERCP
You may not qualify if…
- 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 is running
- The first medical center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
- Department of Gastroenterology, Hongai Hospital — Xiamen, Fujian, China (enrolling)
- Harbin Medical University Affiliated Fourth Hospital — Harbin, Heilongjiang, China (enrolling)
- Zhaolei181220@163.Com — Harbin, Heilongjiang, China (enrolling)
- Huaihe Hospital of Henan University — Kaifeng, Hennan, China (enrolling)
- Renmin hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
- Xijing Hospital of Digestive Diseases — Xi'an, Shaanxi, China (enrolling)
- The 960th Hospital of the PLA — Jinan, Shandong, China (enrolling)
- Eastern Hepatobiliary Surgery Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- the First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
- Jilin Miniciple People'S Hospital — Jilin City, Jilin, China (enrolling)
- Qinghai University Affiliated Hospital — Xining, Qinghai, China (enrolling)
- 986 Hospital of Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
- Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
- Affiliated Hangzhou First People's Hospital — Hangzhou, Zhejiang, China
- the second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
- Shandong Provincial Third Hospital — Jinan, Shandong, China
Full record on ClinicalTrials.gov
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