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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2020-09-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Bile Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plastic Biliary Stent

Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary plastic biliary stent placed across the site of the leak during retrograde cholangiopancreatography (ERCP).

Group Type ACTIVE_COMPARATOR

Plastic biliary stent

Intervention Type DEVICE

Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.

FCSEMS

Subjects with anastomotic bile leaks following orthotopic liver transplant (OLT) will have a temporary fully covered self-expanding metal stent (FCSEMS) placed across the site of the leak during retrograde cholangiopancreatography (ERCP).

Group Type ACTIVE_COMPARATOR

FCSEMS

Intervention Type DEVICE

FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.

Interventions

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Plastic biliary stent

Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.

Intervention Type DEVICE

FCSEMS

FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No