Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue

Phase 2RecruitingNCT07102550

Choon Hyuck David Kwon40 enrolled

Overview

The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults. MiMedx placental tissue grafts are registered with the FDA for homologous use in any location in the body as a protective barrier that supports the healing cascade, which is the use the investigators intend it for in this trial. The main questions this study aims to answer are: 1. Can bile-duct reinforcement using MiMedx placental tissue grafting demonstrate equal-to-improved biliary complications in patients who are recipients of living donor liver transplant? 2. What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting? Participants will: 1. undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits. 2. consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant. 3. consent to allow the study team to perform a review of their medial records after each standard-of-care follow-up visit to assess presence of any biliary complications up to 1 year post-transplant.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Liver Transplant

Interventions

MiMedx AmnioFixBIOLOGICAL

MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults \>/= 18 years old * Recipient of LDLT Exclusion Criteria: * Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee. * Patients \< 18 years old * Patients who cannot provide informed consent * Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT) * Patients who do not wish to participate * Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable populations and will, therefore, be excluded from participation.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Biliary complications

Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.

Time frame: 1 year post living donor liver transplant

Secondary Outcomes

Post-operative Complication Rates

Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection

Time frame: 1 year post living donor liver transplant

Post-operative Hospital Length of Stay

Hospital length of stay

Time frame: From date of transplant until date of discharge from hospital, assessed up to 365 days

Post-operative ICU Length of Stay

ICU length of stay (days)

Time frame: From date of transplant until date of transfer out of ICU, assessed up to 365 days

Readmissions

Number of readmissions post-operatively

Time frame: 1 year post living donor liver transplant