Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MiMedx AmnioFix.
- Who it may be relevant to
- Registry conditions: Liver Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
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.
Detailed description
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.
Interventions
- Biological MiMedx AmnioFix
MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.
Primary outcome measures
- Biliary complications [Time frame: 1 year post living donor liver transplant]
Secondary outcome measures (4)
- Post-operative Complication Rates [Time frame: 1 year post living donor liver transplant]
- Post-operative 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 [Time frame: From date of transplant until date of transfer out of ICU, assessed up to 365 days]
- Readmissions [Time frame: 1 year post living donor liver transplant]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT07102550 · 23-829