jRCT1050230053招募中不适用
Living donor liver transplantation for non-resectable colorectal liver metastases (none)
n/p0 个研究点目标入组 23 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 70age old not（—）
- 性别
- All
入选标准
- •A: criteria for the disease
- •Histological evidence of colorectal adenocarcinoma
- •Genetic examination for RAS, BRAFV600E, MSI, and mismatch repair gene
- •Primary colorectal cancer was curatively resected.
- •Liver metastases from colorectal cancer were diagnosed as surgically non-resectable, including those after repeated hepatectomies. Non-resectable cases are associated with the risk of PHLF owing to insufficient remnant liver volume or function.
- •Non-resectable means the following cases (i) and (ii),
- •(i) Cases in which there is concern of liver failure due to anatomical inability to secure sufficient volume in the remaining liver.
- •Cases in which the residual liver volume does not allow approximately 30% of the total liver volume after resection, or in which tumor invasion of the major vessels makes it difficult to maintain blood flow to the residual liver.
- •(ii) When there is concern about liver failure due to inadequate function of the residual liver caused by liver dysfunction.
- •When the K-ICG value of the residual liver is less than 0.05 in the ICG test.
- •Based on the imaging diagnosis, the metastatic lesion was only present in the liver. Diagnostic imaging modalities include contrast-enhanced computed tomography, magnetic resonance imaging, and fluorodeoxyglucose-positron emission tomography.
- •No history of distant metastases, except in the liver. However, patients with no more than three lung metastases without recurrence for more than six months after treatment are eligible as exceptions.
- •medical therapy was administered more than three months before enrolment.
- •Patients who are at least 18 years old and give written consent to this study.
- •B. Conventional criteria for LDLT
- •Age is >18, <70
- •Main organ function is maintained as follows,
- •Neut: > 1,500/uL
- •Plt: > 30,000/uL
- •Hb: > 7.5 g/dL
- •Cre: <1.5 mg/dL
- •NYHA class II or lower.
- •Hugh-Jones class II or lower.
排除标准
- •Diagnosed as progressive disease after medical therapy evaluated using RESIST version 1.
- •An infectious disease requiring treatment
- •Psychiatric disorder or psychiatric symptoms that interfere with daily life and make it difficult to participate in the study
- •Other cases considered as not eligible for living-donor liver transplantation at each participating institution.
结局指标
主要结局
-
3 year overall survival
次要结局
- Short-term outcomes of living donor liver transplantation(from living donor liver transplantation to discharge from hospital)
- Short-term results of living donor liver transplantation(within 90 days of living donor liver transplantation)
- Tumour recurrence rate
研究者
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