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

NCT03333382 | Terminated Results FDA Device

• 1 other identifier: 171573
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Leak

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Need for Repeat Endoscopic Intervention (ERCP) Within Initial 8 Weeks Following Placement of a Plastic Stent or FCSEMS

  8 weeks

• 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

  90 days

• Need for Repeat OLT

  90 days

• Death at 90 Days

  90 days

Study Arms (2)

Plastic Biliary Stent

ACTIVE COMPARATOR

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

FCSEMS

ACTIVE COMPARATOR

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

Interventions

Plastic biliary stent DEVICE

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

Plastic Biliary Stent

FCSEMS DEVICE

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

FCSEMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients who have undergone OLT with hepaticojejunostomy
• patients who have undergone percutaneous transhepatic cholangiogram with percutaneous biliary intervention following OLT and prior to ERCP

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Limitations and Caveats

One participant screen failed before being randomized to either arm of the study. A second participant was enrolled in August 21, 2018 and was lost to follow-up. No other participants were enrolled. The study remained open in anticipation of enrolling more participants. Post transplant leaks have become less frequent at VUMC, and we struggled to enroll. In September 2020, the decision was made to close the study due to low enrollment.

Results Point of Contact

• Title: Sharee Burkeen, Research Program Manager
• Organization: Vanderbilt University Medical Center

sharee.k.burkeen@vumc.org

(615) 875-7515

Study Officials

• Patrick Yachimski, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: January 30, 2018
• Primary Completion: August 21, 2018
• Study Completion: September 21, 2020
• Last Updated: March 7, 2022
• Results First Posted: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)