The effect of ischaemia/reperfusion injuries by pringle manoeuvre on the prognosis of hepatocellular carcinoma patients after radical excision
| ISRCTN | ISRCTN01960869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01960869 |
| ClinicalTrials.gov number | NCT00725335 |
| Secondary identifying numbers | swhb001 |
- Submission date
- 25/07/2008
- Registration date
- 21/08/2008
- Last edited
- 14/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dong Jiahong
Scientific
Scientific
Institute of Hepatobiliary Surgery
Chinese PLA General Hospital
Beijing
100000
China
| xiaobinf@medmail.com.cn |
Study information
| Study design | Treatment, parallel assignment, two-armed randomised, actively controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics approval pending from the Ethics Committee of Southwest Hospital as of 28/07/2008. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/09/2008 |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/09/2008 |
| Date of final enrolment | 01/12/2014 |
Locations
Countries of recruitment
- China
Study participating centre
Institute of Hepatobiliary Surgery
Beijing
100000
China
100000
China
Sponsor information
Institute of Hepatobiliary Surgery of PLA, Southwest Hospital (China)
University/education
University/education
c/o Feng Xiaobin
Third Military Medical University
30 Gaotanyan Street
Shapinba District
Chongqing
400038
China
"ROR" |
https://ror.org/043sbvg03 |
|---|
Funders
Funder type
Hospital/treatment centre
Institute of Hepatobiliary Surgery of PLA, Southwest Hospital (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/08/2012 | 14/02/2019 | Yes | No |
Editorial Notes
14/02/2019: Publication reference added.
