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) studied | Malignant biliary obstruction |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 80 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Covered WallFlex biliary stent |
Outcome(s)
| Primary Outcome | Stent patency period |
|---|---|
| Secondary Outcome | Stent occlusion rate, Stent-related complication rate, Event free survival, overall survival, success rate of stent removal |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male 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
| Primary Sponsor | Faculty of Medicine, University of Tokyo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Faculty of Medicine, University of Tokyo |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yousuke Nakai |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-3815-5411 |
| 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 |
| Affiliation | Faculty of Medicine, University of Tokyo Department of Gastroenterology |