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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,204
All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure
All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 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
Shijiazhuang, 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 Municipality, China
...and 1 more locations
Rate of post-ERCP Pancreatitis
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.
Time frame: 30 days
Rate of moderate or severe PEP
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.
Time frame: 30 days
Rate of Overall ERCP-related complications
ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Time frame: 30 days
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Time frame: 30 days
Rate of NSAIDs-related complications
NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death
Time frame: 30 days
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