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The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: C-SEMS, inserted above SO | Active Comparator | -In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation. |
|
| Group B: C-SEMS, inserted across SO | Active Comparator | -In group B, small sphincterotomy (50% incision) will be done after biliary cannulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTFE Covered ComVi [full covered] Biliary Stent | Device | The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center. |
| Measure | Description | Time Frame |
|---|---|---|
| Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Death of patients | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Ki Lee, PH.D | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gifu University | Gifu | Japan | ||||
| Onomichi General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Jung Nam Cho, Jimin Han, Ho Gak Kim, IM Hee Shin, Sang Heum Park, Jong Ho Moon, Jin Hong Kim, Don Haeng Lee, Iruru Maetani, Hiroyuki Maguchi, Keiji Hanada, Ichiro Yasuda, Takao Itoi, Hiroyuki Isayama, Dongki Lee. Prospective Randomized Trial Comparing Covered Metal Stent Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction. Gastrointestinal Endoscopy 77(58): AB139-AB140, 2013 |
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|
| PTFE Covered ComVi [full covered] Biliary Stent | Device | The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center. |
|
|
| Onomichi |
| Japan |
| Teine-Keijinkai Hospital | Sapporo | Japan |
| The University of Tokyo | Tokyo | Japan |
| Toho University | Tokyo | Japan |
| Tokyo Medical University | Tokyo | Japan |
| Yamaguchi University | Ube | Japan |
| Soon Chun Hyang University School of Medicine | Bucheon-si | South Korea |
| Soon Chun Hyang University School of Medicine | Cheonan | South Korea |
| Catholic University of Daegu School of Medicine | Daegu | South Korea |
| Inha University School of Medicine | Incheon | South Korea |
| Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| Ajou University School of Medicine | Suwon | South Korea |
| ID | Term |
|---|---|
| D001650 | Bile Duct Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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