Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

Vanderbilt University Medical Center

Status: Completed

Conditions: Distal Bile Duct Obstruction

Treatments: Device: Uncovered Self-expanding metal biliary stents (U-SEMS); Device: Covered Self-expanding metal biliary stents (C-SEMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01905384

130331

Details and patient eligibility

About

The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

Enrollment: 6 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
• 18 years of age or older
• serum bilirubin > 2mg/dL

Exclusion criteria

• prior endoscopic or percutaneous biliary drainage
• post-surgical anatomy
• primary site of biliary obstruction involving the common hepatic duct or hilum
• tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

U-SEMS group

Active Comparator group

Description:

Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).

Treatment:

Device: Uncovered Self-expanding metal biliary stents (U-SEMS)

C-SEMS Group

Active Comparator group

Description:

Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)

Treatment:

Device: Covered Self-expanding metal biliary stents (C-SEMS)