Condition: ERCP · Pancreatitis · Non-steroidal Anti-inflammatory (NSAID) · Sponsor: Air Force Military Medical University, China
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 r…
This description comes directly from the study's public registry record.
Yanglin Pan, MD · 86-84771536 · yanglinpan@hotmail.com
Always discuss trial participation with your own doctor first.
| 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 |
| Renmin hospital of Wuhan University | Wuhan, Hubei, China | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Recruiting |
| The Third Xiangya Hospital of Central South University | Changsha, Hunan, China | Not Yet 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 |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07071441