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

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 Overview

• Status: Terminated
• Conditions: Bile Leak
• Intervention / Treatment: Device: Plastic biliary stent; Device: FCSEMS

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Device: Plastic biliary stent; Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.
Active Comparator: 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).	Device: FCSEMS; FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	90 days
Need for Repeat OLT	Analysis for of need for orthotopic liver transplant (OLT) will be completed.	90 days
Death at 90 Days	Participants will be followed and chart review will be completed to see if death occurred within 90 days.	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.	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.	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.	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.	90 days

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Patrick Yachimski, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): August 21, 2018
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 171573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes