Multicenter, placebo-controlled randomized trial for prevention of post ERCP pancreatitis with Risperidone
- Conditions
- post ERCP pancreatitis
- Registration Number
- JPRN-UMIN000004592
- Lead Sponsor
- Faculty of Medicine, University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Not provided
Patients with a history of ERCP. Patients with acute pancreatitis which need fasting therapy. Patients who have disseminated intravascular coagulation, sepsis, or acute circulatory failure. Patients with more severe disturbance of consciousness than Japan Coma Scale1-1. Patients who have severe heart disease, hepatic insufficiency, renal dysfunction, endocrine disease, or gastrointestinal tract disturbance. Pregnant or breast-feeding women. Women who have possibility of pregnancy or who are not willing to avoid pregnancy during the study. Patients who are treated with risperidone. Patients with severe hypersensitivity to risperidone Patients with mental illness or depression, who need drug therapy or can not comply with the protocol. Patients with Parkinson's disease or parkinsonism. Patients who have received banned drug within 2 weeks before ERCP Patients with chronic pancreatitis Patients who are judged inappropriate by chief (responsive) medical examiner
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints are frequency and severity of post ERCP pancreatitis. Post ERCP pancreatitis is defined according to Consensus Guideline (by Cotton Classification) published in 1991 as follows. 1)Serum amylase level that is three times higher than normal upper limit. 2)Abdominal pain persisting for at least 24 hours.
- Secondary Outcome Measures
Name Time Method 1) Change in serum amylase, pancreatic amylase, and lipase 2) The incidence of abdominal pain and hyperenzymemia.