Rectal NSAIDs With/Without PD Stent for PEP Prevention
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) pla
| Condition(s) | Post-ERCP Acute Pancreatitis, Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent Placement |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 ≤ 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 |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | Air Force Military Medical University, China |
| Locations | Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Harbin, Heilongjiang, China; Harbin, Heilongjiang, China; Kaifeng, Henan, China (+9 more sites) |
| Start date | 2025-07-01 |
| NCT ID | NCT07117318 |
| Official listing | https://clinicaltrials.gov/study/NCT07117318 |