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Indomethacin vs Diclofenac for Preventing PEP

RecruitingNAAges 18 Years - 90 YearsAllAir Force Military Medical University, China
NCT07071441 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (re

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18-90 years old patients with native papilla who planned to undergo ERCP Exclusion Criteria: * Previous biliary sphincterotomy and papillary large balloon dilation * 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
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What it tests

  • Indomethacin 100 MG
  • Diclofenac 100mg
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Where

20 sites
The first medical center, Chinese PLA General Hospital
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Department of Gastroenterology, Hongai Hospital
Xiamen, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, China
Zhaolei181220@163.Com
Harbin, China
Huaihe Hospital of Henan University
Kaifeng, China
Renmin hospital of Wuhan University
Wuhan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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