NIPH Clinical Trials Search

UMIN ID: UMIN000009778

Registered date:14/01/2013

A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBiliary stricture caused by unresectable pancreatic cancer
Date of first enrollment2009/04/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Covered metallic stent (CMS) Uncovered metallic stent (UMS)


Primary Outcomeduration until stent dysfunction
Secondary Outcome1) overall survival 2) incidence of side effect

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) PS > 4. 2) Severe complication of another organ. 3) A patient who gives no written IC. 4) A participating doctor thinks the patient is not proper for this study. 5) Prognosis will be within 3 months. 6) Initial drainage worsen the status of the patient.

Related Information


public contact
Name Kiyohito Tanaka
Address Japan
Telephone 075-231-5171
Affiliation Kyoto Second Red Cross Hospital Department of Gastoroenterology
scientific contact
Name Hidekazu Mukai
Address Awaji 2-9-26, Higashiyodogawa-Ku, Osaka Japan
Telephone 06-6322-2250
Affiliation Yodogawa Christian Hospital Department of Gastroenterology