Study Results
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Basic Information
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RECRUITING
NA
4050 participants
INTERVENTIONAL
2025-06-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Indomethacin
All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure
Indomethacin 100 MG
All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure
Diclofenac group
All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure
Diclofenac 100mg
All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure
Interventions
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Indomethacin 100 MG
All patients without contraindications should receive 100mg rectal indomethacin within 30mins before ERCP procedure
Diclofenac 100mg
All patients without contraindications should receive 100mg rectal diclofenac within 30mins before ERCP procedure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Yanglin Pan
Professor
Locations
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The 960th Hospital of the PLA
Jinan, Shandong, China
The first medical center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Department of Gastroenterology, Hongai Hospital
Xiamen, Fujian, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, China
Huaihe Hospital of Henan University
Kaifeng, Hennan, China
Renmin hospital of Wuhan University
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jilin Miniciple People'S Hospital
Jilin, Jilin, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
986 Hospital of Xijing Hospital
Xi'an, Shaanxi, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Shandong Provincial Third Hospital
Jinan, Shandong, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
the second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lei Zhao
Role: primary
References
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Akshintala VS, Sperna Weiland CJ, Bhullar FA, Kamal A, Kanthasamy K, Kuo A, Tomasetti C, Gurakar M, Drenth JPH, Yadav D, Elmunzer BJ, Reddy DN, Goenka MK, Kochhar R, Kalloo AN, Khashab MA, van Geenen EJM, Singh VK. Non-steroidal anti-inflammatory drugs, intravenous fluids, pancreatic stents, or their combinations for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Sep;6(9):733-742. doi: 10.1016/S2468-1253(21)00170-9. Epub 2021 Jun 30.
Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
Kang X, Xia M, Wang J, Wang X, Luo H, Qin W, Liang Z, Zhao G, Yang L, Sun H, Tao J, Ning B, Zhong L, Zhang R, Ma X, Zhao J, Yue L, Jin H, Kang C, Ren G, Liang S, Wang H, Wang L, Nie Y, Wu K, Fan DM, Pan Y. Rectal diclofenac versus indomethacin for prevention of post-ERCP pancreatitis (DIPPP): a multicentre, double-blind, randomised, controlled trial. Gut. 2025 Jun 6;74(7):1094-1102. doi: 10.1136/gutjnl-2024-334466.
Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.
Other Identifiers
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KY20242439-F-1
Identifier Type: -
Identifier Source: org_study_id
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