KCT0002394
Recruiting
未知
Prevention of Post-ERCP Pancreatitis by Intraduodenal Indomethacin in ERCP naïve patients: Prospective, Randomized, Placebo-controlled, Double blind, Multicenter Study
Chung-Ang Univerisity Hospital0 sites926 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Chung-Ang Univerisity Hospital
- Enrollment
- 926
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age \= 20 or age \= 80, 2\) Patients with naïve papilla and first ERCP, 3\) Diagnostic or therapeutic ERCP, 4\) No evidence of significant abnormality in cardiopulmonary function, 5\) No expectation of adverse event after indomethacin application.
Exclusion Criteria
- •1\) Unwillingness or inability to informed consent for study, 2\) Age \< 20 or \> 80, 3\) Pregnant women, 4\) Lactating women, 5\) Clinical contraindication for ERCP, 6\) History of allergy or hypersensitivity to aspirin or NSAIDs, 7\) Recent history (within 7 days) of NSAIDs medication, 8\) Serum creatinine \> 1\.4 mg/dL, 9\) Active or recent (within 4 weeks) gastrointestinal bleeding, 10\) Active cardiovascular or cerebrovascular disease, 11\) Acute pancreatitis within 72 hours, 12\) Chronic pancreatitis, 13\) ERCP for stent removal or stent change, 14\) Endoscopic sphicterotomy state, 15\) Drug or alcohol abuser, 16\) Psychiatric illness that anticipated inability to follow study protocol.
Outcomes
Primary Outcomes
Not specified
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