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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Ischemia/Reperfusion Injuries Elicited by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Excision:A Multicenter Prospective Randomized Controlled Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: curative resection without Pringle
* Procedure: curative resection with Pringle manoeuvre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A,non-pringle group<br>Intervention of curative resection of HCC Without pringle manoeuvre in this arm | Procedure: curative resection without Pringle<br>* Radical excision of liver cancer without the procedure of pringle manoeuvre<br>* Other names: Experimental group;|
| Active Comparator: pringle group(B)<br>when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied. | Procedure: curative resection with Pringle manoeuvre<br>* curative resection liver cancer under pringle manoeuvre<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 1,3,5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc |  | baseline 2 weeks, 5-year overall survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia, liver cancer, radical excision, prognosis