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

Not Applicable

Completed

• Conditions: Distal Bile Duct Obstruction
• Interventions: Device: Covered Self-expanding metal biliary stents (C-SEMS); Device: Uncovered Self-expanding metal biliary stents (U-SEMS)

• Registration Number: NCT01905384
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Study Start: 2017-11-08
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Results First Submitted: 2021-11-30
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-04
• Last Update Submitted: 2022-03-04
• Results First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-SEMS Group	Covered Self-expanding metal biliary stents (C-SEMS)	Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
U-SEMS group	Uncovered Self-expanding metal biliary stents (U-SEMS)	Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).

Primary Outcome Measures

Name	Time	Method
Rate of Long-term Stent Failure	One year	Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

Secondary Outcome Measures

Name	Time	Method
Rates of Adverse Stent-related or Intervention-related Outcomes	One Year	Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.

Trial Locations

Locations (2)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States