Status:
UNKNOWN
Laparoscopic Versus Open Major Hepatectomy for HCC Hepatectomy for Hepatocellular Carcinoma
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Health and Medicine Research Fund
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Hepatocellular carcinoma (HCC) is the sixth most common malignancy in the world. Major hepatectomy (resection of \> 3 liver segments) is needed if tumor is close to major blood vessels wit...
Detailed Description
Background: Hepatocellular carcinoma (HCC) is the sixth most common malignancy in the world.The practice of screening by ultrasonography and serum alpha-fetoprotein concentration in cirrhotic patients...
Eligibility Criteria
Inclusion
- Diagnosis of HCC is in accordance to the diagnostic criteria for HCC used by the European Association for the Study of the Liver. HCC was diagnosed when the radiologic imaging techniques (spiral contrasted CT scan or contrasted MRI) showed typical features of HCC (contrast enhancement in the arterial phase and rapid wash-out of contrast in the venous or delayed phase) and/or elevated serum alpha fetoprotein (AFP) level.
- HCC of maximum diameter up to 10 cm; Single or multiple tumor nodules confined to one liver lobe according to the previous reported series
- Major hepatectomy (resection of \> 3 Couinaud's segments) is required as judged by hepatobiliary surgeons
- Absence of extrahepatic metastasis or radiological evidence of venous invasion of major portal vein or hepatic vein branches
- Child's A liver function
- Indocyanine green retention at 15 min (ICG-15) \< 15%
- Adequate future liver remnant (image-guided volumetry \> 35% of estimated standard liver volume)
- General condition fit for general anaesthesia
Exclusion
- Tumors unfavorable for major hepatectomy (e.g. bilobar tumors, main portal vein tumor thrombus and/or inadequate future liver volume)
- Previous treatment for HCC (e.g. transarterial chemoembolization, or chemotherapy)
- Tumors require combined hepatectomy and thermal ablation therapy
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04852211
Start Date
December 1 2021
End Date
November 30 2024
Last Update
August 31 2023
Active Locations (1)
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1
Chinese University of Hong Kong
Hong Kong, Hong Kong