Covered Versus Uncovered Biliary Stents for Biliary Malignancies

Nuovo Ospedale Civile S.Agostino Estense

Status: Completed

Conditions: Biliary Tract Cancer

Treatments: Device: covered biliary stents; Device: uncovered biliary stents

Study type: Interventional

Funder types: Other

Identifiers

NCT02102984

242/13

Details and patient eligibility

About

Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

covered stents

Active Comparator group

Description:

endoscopic placement of covered biliary stents

Treatment:

Device: covered biliary stents

uncovered biliary stents

Active Comparator group

Description:

endoscopic placement of uncovered biliary stents

Treatment:

Device: uncovered biliary stents