NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000009779

Registered date:14/01/2013

A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBiliary stricture caused by unresectable middle to lower bile duct cancer
Date of first enrollment2009/03/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Covered metallic stent (CMS) Uncovered metallic stent (UMS)

Outcome(s)

Primary Outcomeduration until stent dysfunction
Secondary Outcome1) overall survival 2) incedence 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

Contact

public contact
Name Kiyohito Tanaka
Address Japan
Telephone 075-231-5171
E-mail
Affiliation Kyoto Secind Red Cross Hospital Department of Gastroenterology
scientific contact
Name Hidekazu Mukai
Address Awaji 2-9-26 Higasiyodogawa-Ku, Osaka Japan
Telephone 06-6322-2250
E-mail
Affiliation Yodogawa Chiristian Hospital Department of Gastroenterology