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) 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. |
|---|---|
| Secondary Outcome | Technical success rate of tube removal and adverse events |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| 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) |
|---|---|
| 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 |