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

Distal Bile Duct Obstruction Clinical Trial

Official title:

Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905384
• Other study ID #: 130331
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholestasis
• Distal Bile Duct Obstruction

Intervention

Device:
• Covered Self-expanding metal biliary stents (C-SEMS)
Used for palliation of inoperable malignant distal bile duct obstruction.
• Uncovered Self-expanding metal biliary stents (U-SEMS)
Used for palliation of inoperable malignant distal bile duct obstructions.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Long-term Stent Failure	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.	One year
Secondary	Rates of Adverse Stent-related or Intervention-related Outcomes	Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.	One Year