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The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Covered metal stent |
|
| 2 | Active Comparator | Uncovered metal stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent) | Device | Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction? | 12 months after stent insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric P Kullman, M.D. | Department of Surgery, University Hostpital, Linkoping, Sweden. | Study Chair |
| Claes Soderlund, M.D. | Department of Surgery, Sodersjukhuset, Stockholm, Sweden. | Principal Investigator |
| Bo Ohlin, M.D. | Department of Surgery, Central Hospital of Blekinge, Karlskrona, Sweden. | Principal Investigator |
| Ervin Toth, M.D. | Department of Endoscopy, University Hospital MAS, Malmö, Sweden. | Principal Investigator |
| Carl-Eric Leijonmarck, M.D. | Department of Surgery, S:t Goran Hospital, Stockholm, Sweden. | Principal Investigator |
| Eduard Jonas, M.D. | Department of Surgery, Danderyd Hospital, Stockholm, Sweden. | Principal Investigator |
| Claes Rudberg, M.D. | Department of Surgery, Central Hospital, Vasteras, Sweden. | Principal Investigator |
| Kalev Teder, M.D. | Department of Surgery, Central Hospital, Norrkoping, Sweden. | Principal Investigator |
| Erik Svartholm, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, University Hospital | Linköping | 58185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21034892 | Derived | Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gozen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010 Nov;72(5):915-23. doi: 10.1016/j.gie.2010.07.036. |
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| Department of Surgery, Ryhov Hospital, Jonkoping, Sweden. |
| Principal Investigator |
| Mehmet Gozen, M.D. | Department of Surgery, Vastervik Hospital, Vastervik, Sweden. | Principal Investigator |
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D010190 | Pancreatic Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001661 | Biliary Tract Neoplasms |
| D005705 | Gallbladder Diseases |
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