NCT03333382

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

Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks Following Orthotopic Liver Transplant (OLT): a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bile Leak

Interventions

Type	Name	Description
DEVICE	Plastic biliary stent	Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.
DEVICE	FCSEMS	FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.

Timeline

• Start date: 2018-01-30
• Primary completion: 2018-08-21
• Completion: 2020-09-21
• First posted: 2017-11-06
• Last updated: 2022-03-07
• Results posted: 2022-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study