NCT03333382

Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks

Terminated NA Results posted Last updated 7 March 2022

What this trial tests

NA trial testing Plastic biliary stent in Bile Leak in 1 participant. Terminated before completion.

Timeline

30 January 2018

Primary endpoint
21 August 2018

21 September 2020

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	30 January 2018
Primary completion	21 August 2018
Estimated completion	21 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Plastic biliary stent
• FCSEMS

Conditions studied

• Bile Leak — all drugs for Bile Leak →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Bile Leak. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary endoprosthesis (stent) across the site of anastomotic leak. While this intervention carries a high rate of technical success, clinical success is not universal. An alternative to placement of a plastic biliary stent is placement of a fully covered self-expanding metal stent (FCSEMS). Whereas a plastic stent functions largely as a wick to siphon bile flow, the theoretical advantage of a FCSEMS is that the relatively larger expansile diameter and membrane coating provide an actual and effective seal at the site of leak. FCSEMS have been used successfully for salvage therapy of anastomotic bile leaks in the post-OLT population with no serious stent related adverse events and no cases of unsuccessful FCSEMS removal in this population.

The objective of this study is to prospectively randomize patients found to have anastomotic bile leaks following OLT to placement of either a plastic biliary stent or a FCSEMS at initial ERCP intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.