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临床试验/NCT06069050
NCT06069050尚未招募不适用

Sequential Adolescent Left Lateral Lobe Liver Transplantation in Adolescents With End-stage Liver Disease: a Single-center, Prospective, Single-arm Study

RenJi Hospital0 个研究点目标入组 20 人开始时间: 2023年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
3-year overall survival

研究概览

简要总结

End-stage liver disease is synonymous with advanced liver disease, liver failure, and decompensated cirrhosis, and their disease progression is generally irreversible. Unlike other end-stage diseases, liver transplantation is a definitive and potentially curative treatment for ESLD. However, due to clinical and social factors such as the shortage of donor livers, the number of patients who can be transplanted is far less than the number of waiting patients. About 14% of patients die each year while waiting, and about 10% of patients are too sick to be transplanted. Although changes in organ allocation policies and popularization of living donor liver transplantation have significantly reduced the waiting time and mortality of infant recipients under 2 years old. Pre-transplant mortality in children older than 6 years remains high. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above patients.Based on the experience of clinical operation, our center proposes and designs the clinical research of sequential adolescent left lateral lobe liver transplantation (SALT) for the treatment of AESLD. On the basis of RAPID, the safety and efficacy of sequential juvenile left lateral lobe liver transplantation were evaluated for the above patients.

详细描述

Cirrhosis is an irreversible advanced stage of chronic progressive liver disease characterized by structural deformation of the liver and the formation of regenerative nodules. Those with complications are classified as decompensated cirrhosis, including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma (HCC), hepatorenal syndrome, or hepatopulmonary syndrome. These complications are the leading cause of death in patients with cirrhosis. End-stage liver disease is synonymous with advanced liver disease, liver failure, and decompensated cirrhosis, and their disease progression is generally irreversible. Unlike other end-stage diseases, liver transplantation is a definitive and potentially curative treatment for ESLD. However, due to clinical and social factors such as the shortage of donor livers, the number of patients who can be transplanted is far less than the number of waiting patients. About 14% of patients die each year while waiting, and about 10% of patients are too sick to be transplanted. Although changes in organ allocation policies and popularization of living donor liver transplantation have significantly reduced the waiting time and mortality of infant recipients under 2 years old. Pre-transplant mortality in children older than 6 years remains high. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, a new surgical method was proposed by Norwegian scholars. Therefore, expanding the donor liver pool is an urgent need to treat patients with adolescent end-stage liver disease (AESLD). In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID). This approach allows transplantation of the left liver (segments 2+3) to an adult recipient, while the remaining enlarged right hemi-liver is transplanted to another adult recipient. Recipients who received right-hemi-liver transplantation had a similar prognosis compared with those who received whole-liver transplantation. Therefore, if the RAPID technique is confirmed to be feasible, it can greatly alleviate the shortage of liver donors. In addition to cadaver sources, living adult donors can also be considered as the source of liver donors. A smaller left lateral lobe donor liver also places less burden on the donor than a left or right hemiliver.

To sum up, our center proposed and designed a clinical study of sequential adolescent left lateral lobe liver transplantation (SALT) in the treatment of AESLD patients based on clinical surgical experience. On the basis of RAPID operation, the overall survival rate of SALT in AESLD patients was evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age 7-18 years old;
  • Patients with end-stage liver disease cannot obtain sufficient donor liver volume through conventional living donor liver transplantation;
  • The general condition is good and can tolerate the follow-up operation plan;
  • Guardians and children (over 14 years old) sign the informed consent.

排除标准

  • Uncorrectable cardiopulmonary disease with excessive surgical risk
  • Anatomical abnormalities precluding liver transplantation
  • Patients with primary or secondary hepatic malignancies
  • Patients with genetic metabolic diseases and their complications that cannot be completely cured by liver transplantation
  • Persistent non-adherence to medical care
  • Combined with AIDS and other diseases that affect surgery or tumor progression
  • Other reasons that the researchers think are not suitable for participation.

结局指标

主要结局

3-year overall survival

时间窗: 3 years after the second liver resection

To describe the 3-year overall survival after sequential adolescent left lateral lobe liver transplantation (SALT) in adolescent patients with end-stage liver disease.

次要结局

  • 1-year overall survival(1 year after the second liver resection)

研究者

申办方类型
Other
责任方
Sponsor

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