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临床试验/NCT02579408
NCT02579408进行中(未招募)不适用

Controlled Attenuation Parameter for the Evaluation of Donor Steatosis in Living Donor Liver Transplantation

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Recipient allograft short-term outcomes

研究概览

简要总结

Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its presence among donors of living donor liver transplants could affect the outcomes of recipients of liver transplantation. By using controlled attenuation parameter (CAP) measurements, the investigators aim to investigate the association of CAP measurements and severity of fatty liver among liver donors in the recipient outcomes of living donor liver transplantation.

详细描述

Living donor liver transplantation (LDLT) has been increasing worldwide due to the critical shortage of cadaveric donors and the rising number of patients awaiting liver transplantation. The long-term survival rates of LDLT are now comparable to that of deceased donor liver transplantation. Currently, two-thirds of all liver transplants performed in Hong Kong are LDLT.

The ultimate goal of LDLT is to guarantee donor safety while optimizing the best possible recipient outcome. Donor liver steatosis is a well-known factor which could influence graft function and long-term outcomes of the recipient allograft, and also affects donor hepatic recovery. When needed, pre-operative liver biopsy is often used for the quantitative assessment of donor steatosis, with LDLT not recommended when steatosis exceeds 30%. Nonetheless, liver biopsy is limited by its invasive nature, sampling error and intra-observer variations. Imaging evaluation for the quantification of steatosis via ultrasonography or computed tomography also has various pitfalls. There is currently no universal consensus on the ideal method in assessing donor steatosis.

Controlled attenuation parameter (CAP) is a novel non-invasive method to quantify hepatic steatosis using ultrasonic attenuations to postulate fat content. It has been demonstrated to have good correlation with the degree of hepatic steatosis in both Western and Asian populations. The investigators aim to evaluate the application of CAP in the donor workup of LDLT and to investigate for its association with post-transplant outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 LDLT donor who has completed donor workup
  • Consents to study entry

排除标准

  • Concomitant liver disease, including chronic hepatitis B and C infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, and increased alcohol intake (30g per week for male, 20g per week for female).

结局指标

主要结局

Recipient allograft short-term outcomes

时间窗: Up to 30 days

Includes: 1. Intraoperative parameters (blood transfusion, operation time etc) 2. Postoperative outcomes (ICU stay, hospital stay, hospital mortality, major postoperative complication etc) Initial poor function, defined as an AST or ALT \>1,500 U/L on two consecutive measurements within the first 72 hours Primary graft nonfunction, defined as poor function of allograft culminating in either death of recipient or retransplant

Recipient allograft long-term outcomes

时间窗: Up to 1 year

Includes: 1. Overall survival 2. Primary graft nonfunction up to 1 year 3. Liver stiffness measurements via transient elastography at 1 year 4. Controlled attenuation parameter measurements at 1 year

次要结局

  • Association of controlled attenuation parameter scores with clinical parameters of LDLT donor(At time of transplant)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wai-Kay Seto

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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