Actively Recruiting
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
Led by Choon Hyuck David Kwon · Updated on 2025-08-03
40
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of using placental tissue grafts in adults undergoing living donor liver transplants. This pilot study aims to see if applying MiMedx placental tissue grafts around the bile duct connection can reduce biliary complications after transplant. The study also evaluates rates of postoperative complications and outcomes within one year after transplant. Participants will receive a living donor liver transplant following standard procedures, with the addition of MiMedx AmnioFix placental tissue graft placed around the biliary anastomosis during surgery. This is a single-arm, non-randomized study where all participants receive this graft. The researchers will monitor participants up to one year after the transplant to assess the impact on biliary complications and other postoperative outcomes. During the study, participants will have pre-procedure, post-procedure, and follow-up visits according to usual transplant care. The study team will review medical records after each follow-up visit to track any biliary complications and other postoperative issues. Outcomes such as hospital stay length, ICU stay, and readmissions will be measured up to one year post-transplant, with safety closely monitored throughout the study period.
CONDITIONS
Brief Title
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Recipient of living donor liver transplant (LDLT)
You will not qualify if you...
- Patients deemed unsafe for participation by the liver transplant selection committee
- Patients under 18 years old
- Patients unable to provide informed consent
- Patients receiving deceased donor liver transplants or not undergoing liver transplant
- Patients who do not wish to participate
- Children, cognitively-impaired persons, pregnant women, students, and house staff under direct supervision of the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From transplant day until hospital discharge
Participants undergo living donor liver transplant with placement of MiMedx placental tissue graft around the biliary anastomosis during surgery. Immediate post-operative care is provided following the transplant.
Hospital stay including ICU and general care visits
Duration - Up to 1 year post-transplant
Participants attend follow-up visits to monitor for biliary complications and other post-operative outcomes up to 1 year after transplant.
Regular follow-up visits as per standard care
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
E
Erlind Allkushi
M
Mary Bilancini
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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