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

NCT ID: NCT00725335

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Keywords

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ischemia liver cancer radical excision prognosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group A,non-pringle group

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

Group Type EXPERIMENTAL

curative resection without Pringle

Intervention Type PROCEDURE

Radical excision of liver cancer without the procedure of pringle manoeuvre

pringle group(B)

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

Group Type ACTIVE_COMPARATOR

curative resection with Pringle manoeuvre

Intervention Type PROCEDURE

curative resection liver cancer under pringle manoeuvre

Interventions

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curative resection without Pringle

Radical excision of liver cancer without the procedure of pringle manoeuvre

Intervention Type PROCEDURE

curative resection with Pringle manoeuvre

curative resection liver cancer under pringle manoeuvre

Intervention Type PROCEDURE

Other Intervention Names

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Experimental group control group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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feng xiaobin

Dr Feng xiaobin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Jiahong, Ph D

Role: STUDY_DIRECTOR

Institue of hepatobiliary surgery,Chinese PLA General Hospital

Locations

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Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 22862951 (View on PubMed)

Related Links

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Other Identifiers

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ISRCTN01960869

Identifier Type: OTHER

Identifier Source: secondary_id

SWHB001

Identifier Type: -

Identifier Source: org_study_id