Covered Versus Uncovered Biliary Stents for Biliary Malignancies
Not Applicable
Completed
- Conditions
- Biliary Tract Cancer
- Interventions
- Device: uncovered biliary stentsDevice: covered biliary stents
- Registration Number
- NCT02102984
- Lead Sponsor
- Nuovo Ospedale Civile S.Agostino Estense
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description uncovered biliary stents uncovered biliary stents endoscopic placement of uncovered biliary stents covered stents covered biliary stents endoscopic placement of covered biliary stents
- Primary Outcome Measures
Name Time Method Relief of malignant biliary obstruction six months Clinical assessment
- Secondary Outcome Measures
Name Time Method cost/effecacy 6 months cost and effectiveness of covered versus uncovered biliary stents
Trial Locations
- Locations (1)
NOCSAE - Viale Giardini 1355
🇮🇹Modena, Italy