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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
curative resection without Pringle
curative resection with Pringle manoeuvre
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring ischemia, liver cancer, radical excision, prognosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of hepatobiliary surgery,southwest hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A,non-pringle group

pringle group(B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2008
Last Updated
November 23, 2012
Sponsor
Southwest Hospital, China
Collaborators
Chinese PLA General Hospital, Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00725335
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
Collaborators
Chinese PLA General Hospital, Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
ischemia, liver cancer, radical excision, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A,non-pringle group
Arm Type
Experimental
Arm Description
Intervention of curative resection of HCC Without pringle manoeuvre in this arm
Arm Title
pringle group(B)
Arm Type
Active Comparator
Arm Description
when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied.
Intervention Type
Procedure
Intervention Name(s)
curative resection without Pringle
Other Intervention Name(s)
Experimental group
Intervention Description
Radical excision of liver cancer without the procedure of pringle manoeuvre
Intervention Type
Procedure
Intervention Name(s)
curative resection with Pringle manoeuvre
Other Intervention Name(s)
control group
Intervention Description
curative resection liver cancer under pringle manoeuvre
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
1,3,5-year
Secondary Outcome Measure Information:
Title
overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc
Time Frame
baseline~2 weeks, 5-year overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Jiahong, Ph D
Organizational Affiliation
Institue of hepatobiliary surgery,Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of hepatobiliary surgery,southwest hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22862951
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22862951
Description
Protocol

Learn more about this trial

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

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