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

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ClinicalTrials.gov Identifier: NCT00725335
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Procedure: curative resection without Pringle Procedure: curative resection with Pringle manoeuvre

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2008
Primary Completion Date : June 2012
Study Completion Date : November 2012
Arms and Interventions

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 Name: 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 Name: control group

Outcome Measures

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 1,3,5-year ]

Secondary Outcome Measures :
  1. overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc [ Time Frame: baseline~2 weeks, 5-year overall survival ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725335

China, Chongqing
Institute of hepatobiliary surgery,southwest hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
Chinese PLA General Hospital
Fudan University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First Affiliated Hospital, Sun Yat-Sen University
Study Director: Dong Jiahong, Ph D Institue of hepatobiliary surgery,Chinese PLA General Hospital
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: feng xiaobin, Dr Feng xiaobin, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT00725335     History of Changes
Other Study ID Numbers: SWHB001
ISRCTN01960869 ( Other Identifier: a organization in UK )
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by feng xiaobin, Southwest Hospital, China:
liver cancer
radical excision

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases