Multicenter, placebo-controlled randomized trial for prevention of post ERCP pancreatitis with Risperidone

Multicenter, placebo-controlled randomized trial for prevention of post ERCP pancreatitis with Risperidone - Tokyo P3R-2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004592

Enrollment

500

Registered

2010-12-01

Start date

2010-12-01

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

post ERCP pancreatitis

Interventions

Risperidone group is orally administered with 2 capsules filled with 1mg risperidone and lactose 50 to 120 minutes before ERCP. Placebo group is administered orally with 2 capsules filled with lacto

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are planned to undergo first ERCP. Written informed consent is obtained from patient before the study.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1) Change in serum amylase, pancreatic amylase, and lipase 2) The incidence of abdominal pain and hyperenzymemia.	—

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