Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac
NCT ID: NCT05947461
Last Updated: 2024-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1204 participants
INTERVENTIONAL
2023-06-01
2024-06-22
Brief Summary
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Up to date, the mechanisms of NSAIDs in preventing pancreatitis were not fully elucidated. Diclofenac and Indomethacin showed similar inhibitory effects in phospholipase A2 and cyclooxygenase pathways. And the peak concentration of diclofenac and indomethacin both occurs between 30 and 90 min after rectal administration. However, diclofenac may be a stronger inhibitor of other pancreatitis-related imflammatory siginals (e.g. nuclear factor kappa-B) than indomethacin. Recently, several meta-analyses found 100mg rectal diclofenac to be more efficacious than 100mg rectal indomethacin. Despite these data, there is no conclusive evidence to prove that rectal diclofenac could provide incremental benefits over indomethacin from high-quality randomized, controlled trials. Therefore, the investigators conducted a multicenter, double-blind, randomized, controlled clinical trial to evaluate the efficacy of rectal diclofenac versus indomethacin for the prevention of post-ERCP pancreatitis in average-risk patients.
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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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diclofenac group
Patients without contraindications in diclofenac group received 100mg rectal diclofenac 30 mins before ERCP procedure.
100mg diclofenac
All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure
Indomethacin group
Patients without contraindications in indomethacin group received 100mg rectal indomethacin 30 mins before ERCP procedure.
100mg indomethacin
All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure
Interventions
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100mg diclofenac
All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure
100mg indomethacin
All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
* Previous biliary sphincterotomy and papillary large balloon dilation
* Acute pancreatitis within 3 days before ERCP
* 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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Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
Xiamen, Fujian, China
Department of Gastroenterology, The 980th Hospital of the PLA Joint Logistics Support Force
Shijiazhuang, Hebei, China
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, China
Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Department of Gastroenterology,The 986th Hospital of Xijing Hospital
Xi'an, Shaanxi, China
Xijing Hospital of Digestive Diseases, Air Force Military Medical University, China
Xi'an, Shaanxi, China
Deparment of hepatobiliary surgery, The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Department of Gastroenterology and Endoscopy, Department of Gastroenterology and EndoscopyThe Third Affiliated Hospital of Naval Military Medical University
Shanghai, Shanghai Municipality, China
Department of Gastroenterology, General Hospital of Xinjiang Military Region
Ürümqi, Xinjiang, China
Countries
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References
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Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
Kang X, Guo X, Chen Z, Zhou Z, Luo H, Lu Y, Lou L, Guo X, Pan Y. The Incidence and Severity of Post-ERCP Pancreatitis in Patients Receiving Standard Administration of NSAIDs: a Systematic Review and Meta-analysis. J Gastrointest Surg. 2022 Nov;26(11):2380-2389. doi: 10.1007/s11605-022-05399-6. Epub 2022 Aug 8.
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.
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.
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.
Other Identifiers
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KY20232165-C-1
Identifier Type: -
Identifier Source: org_study_id
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