NCT00725335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
498

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

3.8 years

First QC Date

July 24, 2008

Last Update Submit

November 23, 2012

Conditions

Hepatocellular Carcinoma

Keywords

ischemialiver cancerradical excisionprognosis

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    1,3,5-year

Secondary Outcomes (1)

  • overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc

    baseline~2 weeks, 5-year overall survival

Study Arms (2)

group A,non-pringle group

EXPERIMENTAL

Intervention of curative resection of HCC Without pringle manoeuvre in this arm

Procedure: curative resection without Pringle

pringle group(B)

ACTIVE COMPARATOR

when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied.

Procedure: curative resection with Pringle manoeuvre

Interventions

curative resection without PringlePROCEDURE

Radical excision of liver cancer without the procedure of pringle manoeuvre

Also known as: Experimental group
group A,non-pringle group
curative resection with Pringle manoeuvrePROCEDURE

curative resection liver cancer under pringle manoeuvre

Also known as: control group
pringle group(B)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy patients
  • With extrahepatic tumor or lymphnode metastasis
  • Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
  • Positive marginal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (1)

  • 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.

    PMID: 22862951DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, HepatocellularIschemiaLiver Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Dong Jiahong, Ph D

    Institue of hepatobiliary surgery,Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Feng xiaobin

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 30, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

CN(1)