Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Biliary complications
研究概览
简要总结
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.
详细描述
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:
- 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?
- What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?
Participants will:
- undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.
- consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >/= 18 years old
- •Recipient of LDLT
排除标准
- •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.
研究组 & 干预措施
Living Donor Liver Transplant (LDLT) graft recipient
LDLT recipient with MiMedx placental graft placement
干预措施: MiMedx AmnioFix (Biological)
结局指标
主要结局
Biliary complications
时间窗: 1 year post living donor liver transplant
Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.
次要结局
- Readmissions(1 year post living donor liver transplant)
- Post-operative Complication Rates(1 year post living donor liver transplant)
- Post-operative ICU Length of Stay(From date of transplant until date of transfer out of ICU, assessed up to 365 days)
- Post-operative Hospital Length of Stay(From date of transplant until date of discharge from hospital, assessed up to 365 days)
研究者
Choon Hyuck David Kwon
Principal Investigator
The Cleveland Clinic