NIPH Clinical Trials Search

UMIN ID: C000000043

Registered date:06/08/2005

A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant common bile duct obstruction
Date of first enrollment2003/02/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Percutaneous endprosthesis using bare stents. Percutaneous endprosthesis using covered stents.


Primary OutcomePatency of bile duct at 24 weeks after stent placement.
Secondary OutcomeTechnical success rate of tube removal and adverse events

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Post choledocho-intestinal anatomosis, hepatocellular carcinoma, duodenal cancer, peritoneal carcinomatosis, mucin-producing tumor. 2) Duodenal or intestinal obstruction. 3) Biliary infection. 4) Pregnancy.

Related Information


public contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Tetsuya Yoshioka
Address 1-30-1, Hiramatsu, Nara 631-0846, Japan Japan
Telephone 0742-46-6001
Affiliation Nara Prefectural Nara Hospital Department of Radiology