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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725335

Enrollment

498

Registered

2008-07-30

Start date

2008-09-30

Completion date

2012-11-30

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

ischemia, liver cancer, radical excision, prognosis

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.

Interventions

PROCEDUREcurative resection without Pringle

Radical excision of liver cancer without the procedure of pringle manoeuvre

PROCEDUREcurative resection with Pringle manoeuvre

curative resection liver cancer under pringle manoeuvre

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease free survival	1,3,5-year

Secondary

Measure	Time frame
overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc	baseline~2 weeks, 5-year overall survival

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026