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
18 Years
65 Years
Both
Hepatocellular Carcinoma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Disease free survival
Outcome Time Frame:
1,3,5-year
Safety Issue:
No
Principal Investigator
Dong Jiahong, Ph D
Investigator Role:
Study Director
Investigator Affiliation:
Institue of hepatobiliary surgery,Chinese PLA General Hospital
Authority:
China: Ethics Committee
Study ID:
SWHB001
NCT ID:
NCT00725335
Start Date:
September 2008
Completion Date:
November 2012
Related Keywords:
- Hepatocellular Carcinoma
- ischemia
- liver cancer
- radical excision
- prognosis
- Carcinoma
- Reperfusion Injury
- Carcinoma, Hepatocellular
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