Intravenous Parecoxib for prevention of Post-ERCP Pancreatitis (PEP) prospective, single center, randomized controlled trial.
Phase 4
- Conditions
- Post ERCP PancreatitisPost ERCP Abdominal pain scoreRisk factor for Post ERCP PancreatitisERCPPancreatitisDynastatParecoxib sodium
- Registration Number
- TCTR20221020002
- Lead Sponsor
- MNRH Institution Review board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 428
Inclusion Criteria
Patients undergoing ERCP at Maharat Nakhon Ratchasima Hospital
Age more than 20 years
Exclusion Criteria
Hypersensitivity/Contraindication to parecoxib, NSAIDs, or sulfonamide
Active/Recent Gastrointestinal bleeding or Recent Peptic ulcer disease within 4 weeks
Renal dysfunction (Cr > 1.5 mg/dL)
History of Myocardial infarction
ECOG 4
NSAIDs use during preceding week (ASA 325 mg daily or less)
Acute pancreatitis less than 2 weeks before ERCP
History of Bilioenteric bypass
History of chronic pancreatitis
Pregnancy or Breast feeding
Patient with HIV infection
Refused to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post ERCP Pancreatitis before patient discharge from admission Criteria for diagnosis Pancreatitis as consensus criteria
- Secondary Outcome Measures
Name Time Method Post operative pain score when patient arrived at inpatient department after ERCP Abdominal pain score ,Risk factor for Post ERCP Pancreatitis within 3 months after end of study Compare incidence of Post ERCP Pancreatitis between Parecoxib and placebo