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 |
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Health condition(s) or Problem(s) studied | Malignant common bile duct obstruction |
Date of first enrollment | 2003/02/01 |
Target sample size | 60 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Percutaneous endprosthesis using bare stents. Percutaneous endprosthesis using covered stents. |
Outcome(s)
Primary Outcome | Patency of bile duct at 24 weeks after stent placement. |
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Secondary Outcome | Technical success rate of tube removal and adverse events |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) 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
Primary Sponsor | Japan Interventional Radiology in Oncology Study Group (JIVROSG) |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
Secondary ID(s) |
Contact
public contact | |
Name | Yasuaki Arai |
Address | 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan |
Telephone | 03-3542-2511 |
jivrosgoffice@ml.res.ncc.go.jp | |
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 |