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临床试验/NCT02613156
NCT02613156已完成不适用

Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

Sun Yat-sen University0 个研究点目标入组 25 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
主要终点
Perioperative complications

研究概览

简要总结

This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of recurrent hepatocellular carcinoma (HCC).

详细描述

The investigators conducted a prospective study of 64 patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014; 31 patients were enrolled in the laparoscopic group and underwent complete laparoscopic resection of HCC, and 33 patients were enrolled in the control group and underwent open surgical resection. The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups. The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.

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

  • recurrent HCC after open surgery
  • recurrent HCC located in any part of the left lateral lobe or the diaphragm side of the right lobe and near the surface of the liver, which resulted in an easier operation
  • no significant surgical contraindications
  • no major vessel or bile duct tumor invasion and metastasis
  • grade A or B liver function or grade C liver function that recovered to grade A after liver-protective treatment;
  • the patient and his/her family was willing to undergo laparoscopic resection.

排除标准

  • major vessel or bile duct tumor invasion
  • recurrent HCC located in the right liver parenchyma and near secondary vessels and bile ducts, resulting in a difficult operation
  • grade C liver function
  • significant surgical contraindications
  • the patient and his/her family declined laparoscopic hepatectomy.

结局指标

主要结局

Perioperative complications

时间窗: within the first 30 days

The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups.

次要结局

  • relapse-free survival(1 year after surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhongguo Zhou

Dr.

Sun Yat-sen University

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