This randomized, double-blinded, prospective study was to determine whether prophylactic oral udenafil will reduce the incidence and the severity of ERCP-induced pancreatitis

Effect of Udenafil on Prophylaxis for Post-ERCP Pancreatitis : Multicenter Randomized, Double-Blind, Placebo-Controlled Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000021

Enrollment

278

Registered

2010-08-19

Start date

2008-11-07

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 100mg (PDE-5 inhibitors) is administered orally prior to ERCP one time.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age, 20 - 80 years 2) Patients who need a ERCP for a diagnosis and/or treatment 3) There were no problem to perform a ERCP 4) No allergy for Udenafil

Exclusion criteria

Exclusion criteria: (1) age under 18 years, (2) intrauterine pregnancy, (3) breast-feeding mother, (4) mental disability, (5) incarceration, (6) acute pancreatitis within the preceding 72 hours before ERCP, (7) current treatment with aspirin, refecoxib, celecoxib, or other nonsteroidal anti-inflammatory drugs (NSAIDs), (8) allergy history to Udenafil, (9) impaired renal function (serum creatinine O2.0 mg/dL), (10) known liver cirrhosis, (11) subjects having had biliary sphincterotomy and now scheduled for repeat biliary therapy (extended sphincterotomy, balloon dilatation of biliary orifice, stone removal) without pancreatogram, or (12) anticipated inability to follow protocol

Design outcomes

Primary

Measure	Time frame
The incidence of post-ERCP pancreatitis	—

Secondary

Measure	Time frame
the frequency of selective cannulation into the bile duct	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Koog Cheon

Konkuk University Medical Center

Outcome results