Amniotic (placental) tissue to protect the bile-duct connection after living-donor liver transplant
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
This trial will try placing a placental (amniotic) tissue graft around the bile-duct connection to see if it lowers complications in adults getting a living-donor liver transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07102550 on ClinicalTrials.gov |
What this trial studies
This single-arm, non-randomized phase 2 pilot enrolls adult recipients of living-donor liver transplants at the Cleveland Clinic who consent to placement of a MiMedx AmnioFix placental tissue graft around the biliary anastomosis during surgery. The graft is intended as a protective barrier to support healing of the bile-duct connection. Participants receive standard pre- and post-operative care and the study team reviews medical records for biliary complications and other postoperative outcomes for up to one year. The primary focus is safety, with descriptive reporting of biliary complication rates and other postoperative events compared to historical expectations.
Who should consider this trial
Good fit: Adults (≥18 years) who are recipients of a living-donor liver transplant at the Cleveland Clinic and can give informed consent are ideal candidates.
Not a fit: Patients receiving deceased-donor transplants, children, pregnant women, cognitively impaired individuals, or anyone judged unsafe for participation by the transplant selection committee are not expected to qualify or benefit.
Why it matters
Potential benefit: If successful, the graft could reduce bile-duct complications and the need for repeat procedures or hospital readmissions after living-donor liver transplant.
How similar studies have performed: Placental (amniotic) tissue grafts have been used successfully as healing barriers in other surgical settings, but their use around biliary anastomoses in liver transplantation is novel and lacks robust prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Choon Hyuck D Kwon, MD, PhD — The Cleveland Clinic
- Study coordinator: Erlind Allkushi
- Email: allkuse2@ccf.org
- Phone: 2164440223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.