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The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.
The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| partially covered SEMS | Active Comparator | Deployment of Partially covered biliary self expandable metal stent |
|
| fully covered SEMS | Active Comparator | Deployment of Fully covered biliary self expandable metal stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| partially covered SEMS | Device | Used for palliation of inoperable malignant distal bile duct obstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of stent patency | From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From the date of randomization until the date of death from any cause, assessed upto 12 months | |
| stent occlusion rate | From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Kyun Lee, M.D., Ph.D. | Contact | 82-2-3410-3409 | leejk@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jong Kyun Lee, M.D., Ph.D. | Samsung Medical Cencer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Cencer | Recruiting | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| fully covered SEMS | Device | Used for palliation of inoperable malignant distal bile duct obstruction. |
|
|
| stent related complication | From the date of randomization until the date of first documented stent related complication, assessed up to 12 months |
| D004066 |
| Digestive System Diseases |