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临床试验/NCT04874259
NCT04874259招募中不适用

Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis; Pilot Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
1 year patient survival

研究概览

简要总结

Unlike hepatocellular carcinoma, liver transplantation in patients with liver metastasis from colorectal cancer is limited in only few centers. Previously, it was not generally implemented due to lack of organs and high recurrence rates after transplantation. However, due to progressive development in treatments, good results such as increased survival rates can be expected even in liver transplant patients with liver metastasis from colorectal cancer, which is known to have poor prognosis. Therefore, the purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.

详细描述

Surgical treatment offers a distinct survival benefit in liver metastasis of colorectal cancer (CRC LM). However, it has been estimated that only 40% of patients are candidates for curative liver resection. Liver transplantation can be considered as one of a treatment option, since all evident disease is removed during procedure. However, it is limited in only few centers due to lack of organs and high recurrence rates after transplantation.

Currently, with help of development in treatments, prognosis after LT in CRC LM is improving. Recent study of LT for CRC LM from Norway demonstrated a 5-year survival of 56%. In addition, cohort study and randomized controlled trials are ongoing in Germany and Canada. Therefore, it seems to be necessary to verify the effectiveness of liver transplantation for CRC LM and to verify it as an alternative treatment if there is no other treatment. The purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.

Potential participants will be evaluated for liver transplantation and must also have a willing, healthy living donor. Unresectable metastasis should be limited to the liver and stable without no other treatment such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation. The suitability of liver transplantation will be evaluated through a multidisciplinary assessment immediately before transplantation. Those participants who undergo liver transplantation will be followed for survival, disease-free survival, and recurrence for 3 years.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Proven colorectal cancer liver metastases without no other treatment (such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation)
  • •Metastasis isolated to liver
  • •Patients selected as a liver transplant recipient at a multidisciplinary meeting
  • •Paitents with a willing, healthy living donor
  • •Willing and able to provide written informed consent

排除标准

  • •Pregnant women
  • •Known history of human immunodeficiency virus (HIV) infection
  • •Patients with active peptic ulcer within 2 weeks of transplantation
  • •Persistent colorectal cancer after colon resection
  • •Hemodynamically unstable prior to liver transplantation
  • •Progression of LM at any timepoint prior to transplant surgery (assessed in a multidisciplinary meeting)

研究组 & 干预措施

Colorectal cancer liver metastasis

Experimental

Liver transplantation for the treatment of unresectable colorectal cancer liver metastasis

干预措施: Living donor liver transplantation (Procedure)

结局指标

主要结局

1 year patient survival

时间窗: 1 year

1 year patient survival

次要结局

  • 1 year disease-free survival(1 year)
  • Recurrence(3 year)
  • 3 year disease-free survival(3 year)
  • 3 year patient survival(3 year)

研究者

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

Nam-Joon Yi

Professor

Seoul National University Hospital

研究点 (1)

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