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临床试验/NCT00851968
NCT00851968已完成不适用

A Prospective Randomized Controlled Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2008年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
overall survival

研究概览

简要总结

Intraoperative bleeding remains a major concern during liver resection. Pringle maneuver is the most frequently used method to occlude inflow blood of the liver.However, experimental and clinical studies have shown than even short periods of clamping produce some degree of ischemia-reperfusion injury that can result in hepatocellular damage,this damage being especially important in patients with abnormal liver parenchyma such as steatosis and cirrhosis. The aim of this study was to evaluate whether the use of selective vascular clamping should be generalized to HCC patients and help to reduce the ischemia-reperfusion injury.

详细描述

From recent animal studies, it can be easily concluded that I/R injury of the liver may be a significant factor, which can promote the primary liver tumor recurrence and metastasis. If it is a truth in human, there must be a big challenge to the Pringle maneuver which was adopted routinely in hepatectomy in the past years. Pringle maneuver during hepatic resection may do harm to the liver function, make the tumor cell more aggressive and tend to recurrence. It is suggested that further strategies may be needed for the prevention and treatment of I/R injury ,early and late recurrences.Selective hepatic vascular clamping (SVC)such as hemihepatic vascular occlusion have been used to minimize ischemic injury during liver surgery, especially in patients with abnormal liver parenchyma. However,these procedure used is likely to depend on the surgeon's training or preference rather than on objective data, there is not any further reported data or RCT studies conducted about the postoperative outcome ,especially liver function.To address these issues,we designed a prospective randomized controlled trial comparing the complete hepatic vascular clamping (Pringle maneuver) and selective hepatic vascular clamping ( portal vein or hemi-hepatic occlusion) in patients undergoing hepatectomy. The main objective was to compare the liver I/R injury of two procedures to the postoperative liver function. The secondary objective was to evaluate the feasibility, safety, efficacy, amount of hemorrhage,postoperative complications ,disease-free and overall survival rate of the 2 procedures.

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
None

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
否

入选标准

  • •with a clinical diagnosis of primary liver cancer, without any adjuvant therapy;
  • •age:18-70years;
  • •suitable for partial hepatectomy without other malignancies;
  • •compensated cirrhosis with Child-Pugh class A, or B.

排除标准

  • •reject to attend;
  • •with any preoperative adjuvant therapy.
  • •with intrahepatic or extrahepatic malignancies;
  • •cirrhosis with Child-Pugh class C

研究组 & 干预措施

Pringle's Maneuver

Active Comparator

Patients with HCC received Pringle's Maneuver in hepatectomy.

干预措施: Pringle's Maneuver (Procedure)

Hemihepatic vascular Clamping

Experimental

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy

干预措施: Hemihepatic vascular Clamping (Procedure)

portal vein occlusion

Experimental

Patients with HCC received portal vein occlusion in hepatectomy

干预措施: Portal vein occlusion (Procedure)

结局指标

主要结局

overall survival

时间窗: 2010

次要结局

  • serum alanine aminotransferase (ALT), bilirubin, prothrombin time, serum albumin and pre-albumin on postoperative 1, 3, 7 day, resection rate, procedure-related complications and hospital mortality,expression of HIF and P-, E-, and L-selectin(2010)

研究者

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

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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