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临床试验/NCT02131441
NCT02131441Unknown不适用

Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2
试验地点
1
主要终点
time of operation

研究概览

简要总结

Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

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

  • Child-pugh A-B
  • Primary hepatocellular carcinoma of the left liver lobe
  • Tumor size ≤5cm in diameter

排除标准

  • Significant abnormal liver function
  • Significant abnormal Heart function
  • Significant abnormal lung function
  • Significant abnormal kidney function

结局指标

主要结局

time of operation

时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

status of the resection margins

时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

bile leakage

时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

abdominal adhesion

时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

amount of bleeding

时间窗: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

次要结局

  • overall survival(Participants will be followed for 5 years.)
  • disease-free survival(Participants will be followed for 5 years.)
  • time to disease recurrence(Participants will be followed for 5 years.)

研究者

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

Ya-jin Chen

Chief of the division of hepatobiliary surgery

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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