Clinical trial NCT03333382: Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks
Official title: Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks Following Orthotopic Liver Transplant (OLT): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bile Leak
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cholangiographic Resolution of Bile Leak at Follow-up ECRP
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS
timeFrame: 8 weeks
measure: Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS
timeFrame: 90 days
measure: Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak
timeFrame: 90 days
measure: Need for Repeat OLT
timeFrame: 90 days
measure: Death at 90 Days
timeFrame: 90 days
measure: Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS
timeFrame: 90 days
measure: Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS
timeFrame: 90 days
measure: Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS
timeFrame: 8 weeks
measure: Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution
timeFrame: 90 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Patrick Yachimski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: