UMIN ID: UMIN000009779
Registered date:14/01/2013
A prospective randomized study of "covered" vs "uncovered" metallic stets for the management of biliary stricture by unresectable lower to middle bile duct cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Biliary stricture caused by unresectable middle to lower bile duct cancer |
| Date of first enrollment | 2009/03/01 |
| Target sample size | 120 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Covered metallic stent (CMS) Uncovered metallic stent (UMS) |
Outcome(s)
| Primary Outcome | duration until stent dysfunction |
|---|---|
| Secondary Outcome | 1) overall survival 2) incedence of side effect |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) PS>4 2) Severe complication of another organ. 3) A patient who gives no written IC. 4) A participating doctor thinks the patient is not proper for this study. 5) Prognosis will be within 3 months. 6) Initial drainage worsen the status of the patient. |
Related Information
| Primary Sponsor | Kansai Endoscopic Device Selection (EDS) Working Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kansai Endoscopic Device Selection (EDS) Working Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kiyohito Tanaka |
| Address | Japan |
| Telephone | 075-231-5171 |
| Affiliation | Kyoto Secind Red Cross Hospital Department of Gastroenterology |
| scientific contact | |
| Name | Hidekazu Mukai |
| Address | Awaji 2-9-26 Higasiyodogawa-Ku, Osaka Japan |
| Telephone | 06-6322-2250 |
| Affiliation | Yodogawa Chiristian Hospital Department of Gastroenterology |