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Rectal NSAIDs With/Without PD Stent for PEP Prevention

RecruitingNAAges 18 Years - 90 YearsAllAir Force Military Medical University, China
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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. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stent (PDS) placement were demonstrated to be effective strategyies to reduce PEP incidences, particlularly in high-risk patients for post-ERCP pancreatitis (PEP). Rectal NSAIDs were easy-to-use and safe, while PDS placement were technically complex and carried higher risks of adverse events. A previous network meta-analysis suggested rectal NSAIDs in combination with PDS placement did not differ from rectal NSAIDs alone in PEP prevention. To invesigate if rectal NSAIDs alone could obivate the need of PDS placement, a recent trial from Elmunzer et al. conducted a randomized trial to inve

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 18-90 years old patients with native papilla who planned to undergo ERCP * high-risk patients for post-ERCP pancreatitis must meet one or more following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation (\>5 cannulation attempts, or \>5mins cannulation time, or \>1 unintentional pancreatic duct cannulation), or ballon dilatation of an intact biliary sphincter โ‰ค 1 min, double-wire cannulation. Additionally, patients were considered high-risk if they fulfilled two or more of the following minor criteria: female gender under 50 years old, a history of recurrent pancreatitis (two or more episodes), three or more contrast injections into the pancreatic duct with at least one injection reaching the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct. 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 * high-risk patients with pancreatic duct wire passages
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What it tests

  • NSAIDs
  • NSAIDs plus PDS
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Where

15 sites
The first medical center, Chinese PLA General Hospital
Beijing, China
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
Xiamen, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The Third Xiangya Hospital of Central South University
Changsha, China

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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