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NCT Number: NCT00725335

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Ischemia Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, 400038, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

curative resection without Pringle

Procedure

Radical excision of liver cancer without the procedure of pringle manoeuvre

Other names: Experimental group

curative resection with Pringle manoeuvre

Procedure

curative resection liver cancer under pringle manoeuvre

Other names: control group

Primary outcomes

  1. Disease free survival

    Time frame: 1,3,5-year

Secondary outcomes

  1. overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc

    Time frame: baseline~2 weeks, 5-year overall survival

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Collaborators

  • Chinese PLA General Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • Fudan University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2008
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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