Condition category
Cancer
Date applied
25/07/2008
Date assigned
21/08/2008
Last edited
23/12/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dong Jiahong

ORCID ID

Contact details

Institute of Hepatobiliary Surgery
Chinese PLA General Hospital
Beijing
100000
China
xiaobinf@medmail.com.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00725335

Protocol/serial number

swhb001

Study information

Scientific title

The effect of ischaemia/reperfusion injuries elicited by pringle manoeuvre on the prognosis of hepatocellular carcinoma patients after radical excision: a multicentre prospective randomised study

Acronym

Study hypothesis

Until now there are two popular procedures during the radical excision of primary liver cancer in China. One is to give a pringle manoeuvre to control the operative blood loss and the other is to use a combination of CUSA and TissueLink to control the bleeding in patients without liver ischaemia. According to recent experimental studies in rats, we know that ischaemia and reperfusion injury may contribute to the metastasis of the tumour, so we hypothesised that ischaemia and reperfusion injuries during the surgery may accelerate the outgrowth of liver cancer cells and affect the survival of the patients. In order to test the actual contribution of ischaemia on humans, we are conducting this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision.

Please note that as of 08/09/2008 the actual start date of the trial is 09/09/2008. The previous anticipated start date of the trial was 15/08/2008.

Ethics approval

Ethics approval pending from the Ethics Committee of Southwest Hospital as of 28/07/2008.

Study design

Treatment, parallel assignment, two-armed randomised, actively controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hepatitis B virus related primary hepatocellular carcinoma

Intervention

Experimental group: radical excision of liver cancer without liver ischaemia
Control group: radical excision of liver cancer under pringle manoeuvre

The total duration of follow-up for all treatment arms will be five years after the first radical excision operation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Disease free survival, measured 1, 3 and 5 years after the first radical excision operation
2. Total survival, measured 1, 3 and 5 years after the first radical excision operation

Secondary outcome measures

1. Liver function test, measured at each follow-up timepoint, that is 1, 2, 4, 6, 8, 12, 16, 20, 24, 30, 36, 42, 48, 54 and 60 months after the first radical excision operation
2. Hospital stay, measured during peri-operation period
3. Intensive care unit stay, measured during peri-operation period

Overall trial start date

09/09/2008

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current as of 11/09/2008:
The following changes have been made to the below two points of the inclusion criteria:
4. Hepatitis B surface antigens (HBsAg) positive
5. Tumour nodes in the liver can be radically excised

Initial inclusion criteria:
1. Aged from 18 to 65 years, without gender restriction
2. Clinical diagnosis of resectable primary liver cancer
3. The liver function tests showed: Child-Pugh grade A; clearance of indocyanine green at 15 minutes (CICG-R15) of 20%
4. Hepatitis B surface antigens (HBsAg) positive, hepatitis B deoxyribonucleic acid (HBV-DNA) less than 100,000 copies/ml
5. No more than two tumour nodes in the liver
6. No preoperative anti-cancer therapy
7. Written informed consent from the patient or legal guardian prior to entering the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Pregnancy
2. With extrahepatic tumour or lymph node metastasis
3. Tumour invasion or thrombosis in portal vein, hepatic vein or inferior vena cava
4. Surgical marginal positive

Recruitment start date

09/09/2008

Recruitment end date

01/12/2014

Locations

Countries of recruitment

China

Trial participating centre

Institute of Hepatobiliary Surgery
Beijing
100000
China

Sponsor information

Organisation

Institute of Hepatobiliary Surgery of PLA, Southwest Hospital (China)

Sponsor details

c/o Feng Xiaobin
Third Military Medical University
30 Gaotanyan Street
Shapinba District
Chongqing
400038
China

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Institute of Hepatobiliary Surgery of PLA, Southwest Hospital (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes