Multicenter, randomized trial for protection of post ERCP pancreatitis with/without Risperidone(Tokyo P3R)

UMIN ID: UMIN000000505

Registered date:27/10/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: protection of post ERCP pancreatitis
• Date of first enrollment: 2006/07/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Observations of patient is conducted between 24 hours before ERCP and the start of manipulation . Risperidone is administered between 2 and 0.5 hours before ERCP in group of Risperidone.Urinastatin at dose of 150000 units is administered 10 minutes before ERCP .Observations of patient is conducted 3,18 hours after ERCP.And 48 hours as needed.
Observations of patient is conducted between 24 hours before ERCP and the start of manipulation.Urinastatin at dose of 150000 units is administered 10 minutes before ERCP in Urinastatin groups.Observations of patient is conducted 3,18 hours after ERCP.And 48 hours as needed.

Outcome(s)

• Primary Outcome: Percentage of post ERCP pancreatitis patient.The standard basis for diagnostic criterion of post ERCP pancreatitis are as follows. Over three times more than exceed the serum amylase level limit after 18hours post ERCP.Epigastric pain of more than 24 hours.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 76years-old
• Gender: Male and Female
• Exclude criteria: Patients with a history of Endoscopic sphincterotomy. Patients have acute pancreatitis or acute exacerbation of chronic pancreatitis need the fasting therapy. Patients have disseminated intravascular coagulation,sepsis,acute. Patients have severe disturbance of consciousness than Japan Coma Scale1-1. Patients have severeheart disease,hepatic insufficiency,compromised renal function,endocrine disease,and gastrointestinal tract disturbance. Pregnant and breast-feeding women or women suspected of being pregnant,women are not willing to avoid pregnancy during the duration of study . Patients on Risperidone. Patients with a history of severe hypersensitivity to the Risperidone and Urinastatin. Patients have mental illness or depression who need continued medication or can not comply with the protocol. Patients with Parkinson's disease or parkinsonism. Patients receiving banned drug within 2 weeks before pre-observations. Patients with a history of enrolled in this clinical trial. Somebody who are found unfit to be patients by investigator.

Related Information

• Primary Sponsor: Faculty of Medicine, University of Tokyo
• Source(s) of Monetary Support: nothing