Actively Recruiting
Led by Air Force Military Medical University, China · Updated on 2025-12-03
4050
Participants Needed
20
Research Sites
N/A
Total Duration
Researchers are investigating whether 100mg of rectal indomethacin is more effective than the same dose of rectal diclofenac in preventing pancreatitis after an endoscopic retrograde cholangiopancreatography (ERCP) procedure. Pancreatitis is a serious and common complication of ERCP, linked to occasional deaths, longer hospital stays, and higher healthcare costs. Previous studies showed that both 100mg indomethacin and diclofenac could reduce post-ERCP pancreatitis, but it is unclear which drug is superior. The study is a multicenter, randomized, double-blind trial where patients receive either 100mg rectal indomethacin or 100mg rectal diclofenac within 30 minutes before their ERCP procedure, provided they have no contraindications. The trial aims to enroll enough participants to determine if indomethacin is better than diclofenac at preventing post-ERCP pancreatitis. Participants will be monitored for 30 days after the procedure to assess the rate of post-ERCP pancreatitis and its severity, as well as other complications like perforation, infection, bleeding, NSAID-related side effects, and mortality. Safety and adverse events will be closely followed, and the overall impact of the two drugs on preventing pancreatitis will be evaluated over this period.
CONDITIONS
Indomethacin vs Diclofenac for Preventing PEP
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single dose of either 100mg rectal indomethacin or 100mg rectal diclofenac within 30 minutes before the ERCP procedure to prevent post-ERCP pancreatitis.
1 visit (in-person) at the time of ERCP procedure
Duration - 30 days
Participants are monitored for adverse events and rates of post-ERCP pancreatitis and related complications.
Follow-up visits or contacts as needed over 30 days
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 City, 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
Y
Yanglin Pan, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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