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Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction
This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fc-SEMS with anchoring plastic stent | Experimental | fully covered self-expanable metal stent with an external anchoring plastic stent |
|
| uc-SEMS | Active Comparator | uncovered self-expandable metal stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fully covered self-expandable metal stent with an anchoring external plastic stent | Device | Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patent stent | The number of patient without stent dysfuction divided by total number of patients | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stent obstruction | Suspected by jaundice (Total bilirubin > 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP | 1 year |
| Stent migration | Radiologic finding of migration through Abdomen X-ray or CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Hyub Lee, MD, PhD | Contact | 82-2072-2228 | gidoctor@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang Hyub Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| uncovered self-expandable metal stent | Device | Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent |
|
| 1 year |
| Re-intervention | Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage | 1 year |
| Adverse event | acute cholangitis, acute cholecystitis, acute pancreatitis | 1 year |
| Overall survival | Timespan from the diagnosis to the death | 1 year |