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Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| covered stents | Active Comparator | endoscopic placement of covered biliary stents |
|
| uncovered biliary stents | Active Comparator | endoscopic placement of uncovered biliary stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| covered biliary stents | Device | endoscopic placement of covered biliary stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of malignant biliary obstruction | Clinical assessment | six months |
| Measure | Description | Time Frame |
|---|---|---|
| cost/effecacy | cost and effectiveness of covered versus uncovered biliary stents | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| gallbladder in situ | Acute cholecystitis could affect the clinical outcome of patients when a covered stent is used | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Conigliaro, MD | Digestive Endoscopy Unit-NOCSAE- Modena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOCSAE - Viale Giardini 1355 | Modena | 41126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23617653 | Background | Isayama H, Nakai Y, Kogure H, Yamamoto N, Koike K. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered? Dig Endosc. 2013 May;25 Suppl 2:71-4. doi: 10.1111/den.12078. | |
| 29653120 | Derived | Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018 Aug;88(2):283-291.e3. doi: 10.1016/j.gie.2018.03.029. Epub 2018 Apr 11. |
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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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| uncovered biliary stents | Device | endoscopic placement of uncovered biliary stents |
|
|
| D004066 |
| Digestive System Diseases |