Covered Versus Uncovered Biliary Stents for Biliary Malignancies

Nuovo Ospedale Civile S.Agostino Estense140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Biliary Tract Cancer

Interventions

covered biliary stentsDEVICE

endoscopic placement of covered biliary stents

uncovered biliary stentsDEVICE

endoscopic placement of uncovered biliary stents

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NOCSAE - Viale Giardini 1355

Modena, Italy

Outcomes

Primary Outcomes

Relief of malignant biliary obstruction

Clinical assessment

Time frame: six months

Secondary Outcomes

cost/effecacy

cost and effectiveness of covered versus uncovered biliary stents

Time frame: 6 months

Data from ClinicalTrials.gov

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