NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000002293

Registered date:08/08/2009

A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant biliary obstruction
Date of first enrollment2009/06/01
Target sample size80
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Covered WallFlex biliary stent

Outcome(s)

Primary OutcomeStent patency period
Secondary OutcomeStent occlusion rate, Stent-related complication rate, Event free survival, overall survival, success rate of stent removal

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria:Patients for whom endoscopic biliary drainage is difficult. :Patients with hilar malignant biliary obstruction :Patients with duodenal obstruction :Patients with massive ascites :Patients with performance status>=3 :Patients with severely impaired organ function :Patients without written informed consent :Patients considered ineligible for this study.

Related Information

Contact

public contact
Name Yousuke Nakai
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411
E-mail
Affiliation Faculty of Medicine, University of Tokyo Department of Gastroenterology
scientific contact
Name Hiroyuki Isayama
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411
E-mail
Affiliation Faculty of Medicine, University of Tokyo Department of Gastroenterology