Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: curative resection without Pringle; Procedure: curative resection with Pringle manoeuvre

• Registration Number: NCT00725335
• Lead Sponsor: Southwest Hospital, China

Brief Summary

This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients.

Detailed Description

Until now there are two popular procedures during the radical excision of primary liver cancer in our country.One is to give a pringle manoeuvre to control the operative blood loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while without liver ischemia.According to the recent experimental studies in rats,we know that the ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to test the actual contribution of ischemia on human,we conduct this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision.

Study Timeline

• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Study Start: 2008-09
• Primary Completion: 2012-06
• Status Verified: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-23
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

• Clinical diagnosis of resectable primary liver cancer
• The liver function showed:Child-Pugh A，ICG-R15 < 20%
• HbsAg (+)
• tumor nodes in the liver were singular or multiple and could be radical excision
• No preoperative anti-cancer therapy
• Written informed consent from the patient or legal guardian prior to entering the study

Exclusion Criteria

• Pregnancy patients
• With extrahepatic tumor or lymphnode metastasis
• Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
• Positive marginal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A,non-pringle group	curative resection without Pringle	Intervention of curative resection of HCC Without pringle manoeuvre in this arm
pringle group(B)	curative resection with Pringle manoeuvre	when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied.

Primary Outcome Measures

Name	Time	Method
Disease free survival	1,3,5-year

Secondary Outcome Measures

Name	Time	Method
overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc	baseline~2 weeks, 5-year overall survival

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,southwest hospital; 🇨🇳 Chongqing, Chongqing, China