Prevention of post-ERCP pancreatitis

Prevention of Post-ERCP Pancreatitis by Combination of Udenafil and Aceclofenac in High-risk Patients: Prospective, Randomized, Placebo-controlled, Double blind, Multicenter Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000203

Enrollment

226

Registered

2011-10-13

Start date

2012-01-04

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Udenafil 200mg and aceclofenac 100mg are given 2 hours before ERCP for treatment arm. Identical placebos were given for control group.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who required ERCP for diagnosis or treatment 2) Patients who have an acceptable cardiopulmonary status for ERCP 3) Patients who have no risk for aggravation of cardiac function by taking udenafil 4) Patient who are 20-80 year-old and meet one of following (1) Suspected sphincter of Oddi dysfunction (2) Diameter of extrahepatic bile duct < or = 8mm (3) pancreatography is required during ERCP

Exclusion criteria

Exclusion criteria: 1) Need for emergency ERCP 2) Chronic pancreatitis 3) Acute pancreatitis within 72 hours before ERCP 4) Sphincterotomy or sphincterplasty state 5) Periampullary cancer involving sphincter of Oddi 6) Stroke, MI, CABG within 6m 7) Cardiac failure, unstable angina within 6m 8) NSAIDs within 1 week

Design outcomes

Primary

Measure	Time frame
Frequency of pancreatitis	—

Secondary

Measure	Time frame
Safety of udenafil	—

Countries

Korea, Republic of

Contacts

Public ContactHyoung-Chul Oh

Chung-Ang University

Outcome results