Clinical trial NCT00725335: Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: ischemia
liver cancer
radical excision
prognosis
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Fudan University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2008-07-30
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Disease free survival
timeFrame: 1,3,5-year
Secondary outcomes:
measure: overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc
timeFrame: baseline~2 weeks, 5-year overall survival
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,southwest hospital
state: Chongqing
Study officials:
affiliation: Institue of hepatobiliary surgery,Chinese PLA General Hospital
name: Dong Jiahong, Ph D
role: STUDY_DIRECTOR
References:
citation: Xiaobin F, Shuguo Z, Jian Z, Yudong Q, Lijian L, Kuansheng M, Xiaowu L, Feng X, Dong Y, Shuguang W, Ping B, Jiahong D. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial. BMC Cancer. 2012 Aug 3;12:340. doi: 10.1186/1471-2407-12-340.