Indomethacin vs Diclofenac for Preventing PEP
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
| Condition(s) | ERCP, Pancreatitis, Non-steroidal Anti-inflammatory (NSAID), Indomethacin, Diclofenac |
|---|---|
| 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. 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 10 |
| Who can participate | 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 |
| 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, Hennan, China (+14 more sites) |
| Start date | 2025-06-01 |
| NCT ID | NCT07071441 |
| Official listing | https://clinicaltrials.gov/study/NCT07071441 |