The effect of ischaemia/reperfusion injuries by pringle manoeuvre on the prognosis of hepatocellular carcinoma patients after radical excisio

Not Applicable

Completed

• Conditions: Hepatitis B virus related primary hepatocellular carcinoma; Cancer; Malignant neoplasm of liver and intrahepatic bile ducts

• Registration Number: ISRCTN01960869
• Lead Sponsor: Institute of Hepatobiliary Surgery of PLA, Southwest Hospital (China)

Brief Summary

2012 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22862951 [added 14/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-21
• Study Completion: 2014-12-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Disease free survival, measured 1, 3 and 5 years after the first radical excision operation<br> 2. Total survival, measured 1, 3 and 5 years after the first radical excision operation<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Hospital stay, measured during peri-operation period<br> 3. Intensive care unit stay, measured during peri-operation period<br>