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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000505
Enrollment
500
Registered
2006-10-27
Start date
2006-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

protection of post ERCP pancreatitis

Interventions

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

Sponsors

Faculty of Medicine, University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are planned ERCP.Patients who fully understand and are willing to give a written informed consent about participation.circulatory failure.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHiroyuki Isayama

Faculty of Medicine, University of Tokyo Department of Gastroenterology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026