Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac
- Conditions
- Post-ERCP Acute PancreatitisDiclofenacIndomethacinNSAIDsEndoscopic Retrograde Cholangiopancreatography
- Interventions
- Registration Number
- NCT05947461
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
Post-ERCP pancreatitis (PEP) is the most common complication after ERCP, which was associated with occasional mortality, prolonged hospital days and increased health costs. Some studies investigated the effectiveness of different Nonsteroidal antiinflammatory drugs (NSAIDs) for prevent PEP. However, several high-quality RCTs and meta-analyses consistently demonstrated only100mg rectal indomethacin or diclofenac significantly reduced PEP incidence compared with placebos. Thus, European Society of Gastrointestinal Endoscopy, American Society for Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines recommended rountine administration of 100mg rectal indomethacin or diclofenac in unselected patients who underwent ERCP.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1204
- 18-90 years old patients planned to undergo ERCP
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indomethacin group 100mg indomethacin Patients without contraindications in indomethacin group received 100mg rectal indomethacin 30 mins before ERCP procedure. diclofenac group 100mg diclofenac Patients without contraindications in diclofenac group received 100mg rectal diclofenac 30 mins before ERCP procedure.
- Primary Outcome Measures
Name Time Method Rate of post-ERCP Pancreatitis 30 days The diagnosis of post-ERCP pancreatitis was confirmed if there was new onset of upper abdominal pain associated with an increased amylase or lipase level of at least 3 times the upper limit of normal range at 24 hours after ERCP, accompanied with extension of hospitalization for at least 2 nights.
- Secondary Outcome Measures
Name Time Method Rate of Overall ERCP-related complications 30 days ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria 30 days Rate of moderate or severe PEP 30 days The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
Rate of NSAIDs-related complications 30 days NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death
Trial Locations
- Locations (11)
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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
🇨🇳Shijia Zhuang, 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, China
Department of Gastroenterology, General Hospital of Xinjiang Military Region
🇨🇳Urumqi, Xinjiang, China