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

This study has been completed.
Sponsor:
Collaborators:
Chinese PLA General Hospital
Fudan University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
feng xiaobin, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT00725335
First received: July 24, 2008
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

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 Intervention
Hepatocellular Carcinoma
Procedure: curative resection without Pringle
Procedure: curative resection with Pringle manoeuvre

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc [ Time Frame: baseline~2 weeks, 5-year overall survival ] [ Designated as safety issue: No ]

Enrollment: 498
Study Start Date: September 2008
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725335

Locations
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
Investigators
Study Director: Dong Jiahong, Ph D Institue of hepatobiliary surgery,Chinese PLA General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: feng xiaobin, Dr Feng xiaobin, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT00725335     History of Changes
Other Study ID Numbers: SWHB001, ISRCTN01960869
Study First Received: July 24, 2008
Last Updated: November 23, 2012
Health Authority: China: Ethics Committee

Keywords provided by Southwest Hospital, China:
ischemia
liver cancer
radical excision
prognosis

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

ClinicalTrials.gov processed this record on November 20, 2014