Actively Recruiting
Indomethacin vs Diclofenac for Preventing PEP
Led by Air Force Military Medical University, China · Updated on 2025-12-03
4050
Participants Needed
20
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Indomethacin vs Diclofenac for Preventing PEP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 90 years
- Scheduled for ERCP with native papilla
You will not qualify if you...
- Previous biliary sphincterotomy or papillary large balloon dilation
- Planned placement of pancreatic duct stents
- Allergy to NSAIDs
- NSAID use within 7 days before the procedure
- Unsuitable for NSAIDs due to recent gastrointestinal bleeding, renal dysfunction, or coagulopathy
- Acute pancreatitis within 7 days or with pancreatic edema and fluid collections
- Hemodynamical instability
- Pregnancy or breastfeeding
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 20 locations
1
The first medical center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 404100
Actively Recruiting
3
Department of Gastroenterology, Hongai Hospital
Xiamen, Fujian, China, 361000
Actively Recruiting
4
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
5
Zhaolei181220@163.Com
Harbin, Heilongjiang, China, 150000
Actively Recruiting
6
Huaihe Hospital of Henan University
Kaifeng, Hennan, China, 475000
Actively Recruiting
7
Renmin hospital of Wuhan University
Wuhan, Hubei, China, 430000
Actively Recruiting
8
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
9
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
10
Jilin Miniciple People'S Hospital
Jilin, Jilin, China, 132000
Actively Recruiting
11
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000
Not Yet Recruiting
12
986 Hospital of Xijing Hospital
Xi'an, Shaanxi, China, 710000
Actively Recruiting
13
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
14
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710000
Actively Recruiting
15
Shandong Provincial Third Hospital
Jinan, Shandong, China, 250000
Not Yet Recruiting
16
The 960th Hospital of the PLA
Jinan, Shandong, China, 250000
Actively Recruiting
17
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
18
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
19
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
20
the second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
Y
Yanglin Pan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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