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

Army Medical University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: curative resection without Pringle; Procedure: curative resection with Pringle manoeuvre

Study type: Interventional

Funder types: Other

Identifiers

NCT00725335

ISRCTN01960869 (Other Identifier)

SWHB001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 498 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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498 participants in 2 patient groups

group A,non-pringle group

Experimental group

Description:

Intervention of curative resection of HCC Without pringle manoeuvre in this arm

Treatment:

Procedure: curative resection without Pringle

pringle group(B)

Active Comparator group

Description:

when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied.

Treatment:

Procedure: curative resection with Pringle manoeuvre