Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/21/2018 |
| Start Date: | January 30, 2018 |
| End Date: | May 2023 |
Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks Following Orthotopic Liver Transplant (OLT): a Randomized Controlled Trial
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.
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.
Inclusion Criteria:
- adult patients undergoing ERCP for suspected anastomotic bile leak within 60 days
following OLT with standard biliary reconstruction
- cognitively impaired population with a surrogate who has legal power of attorney
Exclusion Criteria:
- patients who have undergone OLT with hepaticojejunostomy
- patients who have undergone percutaneous transhepatic cholangiogram with percutaneous
biliary intervention following OLT and prior to ERCP
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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