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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.
FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cholangiographic Resolution of Bile Leak at Follow-up ECRP
Adjudication of the primary study endpoint will be determined by the presence/absence of persistent anastomotic bile leak at first follow-up endoscopic retrograde cholangiopancreatography (ERCP) after initial stent placement, whether performed at 6 weeks or sooner.
Time frame: up to 6 weeks
Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS
Analysis for need of repeat endoscopic intervention (ERCP) within initial 8 weeks following placement of a plastic stent or FCSEMS will be completed.
Time frame: 8 weeks
Need for Percutaneous Drainage of Biloma or Intraabdominal Fluid Collection Following Placement of a Plastic Stent or FCSEMS
Participants will be analyzed regarding need for percutaneous drainage of biloma or intraabdominal fluid collection following placement of a plastic stent or FCSEMS.
Time frame: 90 days
Need for Surgical Biliary Reconstruction for Refractory Anastomotic Bile Leak
Participants will be analyzed for need of surgical biliary reconstruction for refractory anastomotic bile leak
Time frame: 90 days
Need for Repeat OLT
Analysis for of need for orthotopic liver transplant (OLT) will be completed.
Time frame: 90 days
Death at 90 Days
Participants will be followed and chart review will be completed to see if death occurred within 90 days.
Time frame: 90 days
Rate of Post-ERCP Pancreatitis (PEP) Following Placement of a Plastic Stent vs FCSEMS
Analysis will be performed to determine rate of post-ERCP pancreatitis (PEP) following placement of a plastic stent vs FCSEMS.
Time frame: 90 days
Rate of Stent Migration Following Placement of a Plastic Stent vs FCSEMS
Analysis will be performed to determine the rate of stent migration following placement of a plastic stent vs FCSEMS.
Time frame: 90 days
Rate of Anastomotic Biliary Stricture at Follow-up ERCP 8 Weeks Following Placement of a Plastic Stent or FCSEMS
Rate of anastomotic biliary stricture at follow-up ERCP 8 weeks following placement of a plastic stent or FCSEMS will be analyzed during the course of the study.
Time frame: 8 weeks
Need for Repeat ERCP for Management of Anastomotic Biliary Stricture Within 90 Days Following Leak Resolution
Participants will be analyzed for need of repeat ERCP for management of anastomotic biliary stricture within 90 days following leak resolution.
Time frame: 90 days
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