NCT02102984
Completed
Not Applicable
Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
ConditionsBiliary Tract Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Biliary Tract Cancer
- Sponsor
- Nuovo Ospedale Civile S.Agostino Estense
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Relief of malignant biliary obstruction
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
Detailed Description
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.
Investigators
Rita Conigliaro, MD
Chief - Endoscopy Unit
Nuovo Ospedale Civile S.Agostino Estense
Eligibility Criteria
Inclusion Criteria
- •adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
- •not eligible for surgical intervention
- •able to provide informed consent
Exclusion Criteria
- •benign biliary obstruction
- •previous surgery of the biliary tract
- •life expectancy \< 3 months
Outcomes
Primary Outcomes
Relief of malignant biliary obstruction
Time Frame: six months
Clinical assessment
Secondary Outcomes
- cost/effecacy(6 months)
Study Sites (1)
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