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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725335
• Other study ID #: SWHB001
• Secondary ID: ISRCTN01960869
• Status: Completed
• Phase: N/A
• First received: July 24, 2008
• Last updated: November 23, 2012
• Start date: September 2008
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• curative resection without Pringle
Radical excision of liver cancer without the procedure of pringle manoeuvre
• curative resection with Pringle manoeuvre
curative resection liver cancer under pringle manoeuvre

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,southwest hospital	Chongqing	Chongqing

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		1,3,5-year	No
Secondary	overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc		baseline~2 weeks, 5-year overall survival	No

External Links

•   Protocol