UMIN ID: UMIN000000738
Registered date:11/06/2007
A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Distal malignant biliary obstraction |
| Date of first enrollment | 2007/06/01 |
| Target sample size | 112 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Insertion of covered self expandable metal stents Insertion of uncovered self expandable metal stents |
Outcome(s)
| Primary Outcome | Comparison of the duration of the stents patency |
|---|---|
| Secondary Outcome | comparison of the safty comparison of the cost |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1, Patients with severe dysfunction of liver, kidney, heart, or lung. 2, Patients who are estimated to die within two months. 3,Patients with history of insertion of biliay metal stents 4, Patients with history of surgery of the common bile ducts. 5, Patients with stenosis of the hepatic ducts or the intra hepatic bile ducts. 6, Patients with stenosis of the duodenum which prevent passage of foods. |
Related Information
| Primary Sponsor | International Medical Center of Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan Japan |
| Telephone | |
| mkobaya@imcj.hosp.go.jp | |
| Affiliation | International Medical Center of Japan Department of gastroenterology |
| scientific contact | |
| Name | Masao Kobayakawa |
| Address | 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | International Medical Center of Japan Department of gastroenterology |