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

November 23, 2012 updated by: feng xiaobin, Southwest Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

498

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Institute of hepatobiliary surgery,southwest hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group A,non-pringle group
Intervention of curative resection of HCC Without pringle manoeuvre in this arm
Procedure: curative resection without Pringle
Radical excision of liver cancer without the procedure of pringle manoeuvre
Other Names:
  • Experimental group
ACTIVE_COMPARATOR: pringle group(B)
when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied.
Procedure: curative resection with Pringle manoeuvre
curative resection liver cancer under pringle manoeuvre
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Collaborators

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

Investigators

  • Study Director: Dong Jiahong, Ph D, Institue of hepatobiliary surgery,Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 29, 2008

First Posted (ESTIMATE)

July 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 23, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWHB001
  • ISRCTN01960869 (OTHER: a organization in UK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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