Clinical trial NCT03766555: Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function
Official title: Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma
Hepatectomy
Microwave Ablation
Local Ablation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized study to be conducted in an academic hospital with a specialized hepato-biliary team. The principal investigator and other members within the team will perform patient selection and recruitment of this study according to the inclusion and exclusion criteria.
Primary purpose: TREATMENT

Brief summary: We propose a randomized controlled study to compare the treatment efficacy of microwave ablation to liver resection for hepatocellular carcinoma (HCC) in patients with borderline liver function.

Detailed description: Hepatocellular carcinoma (HCC) is a common cancer and is diagnosed at an earlier stage and with increasing frequency because of the wider implementation of screening programs. Whether liver resection or local ablation should be the first-line treatment in early HCC remains a hot topic for debate. Both are regarded as acceptable curative treatment for early HCC in many international guidelines. Underlying liver function is the key in treatment selection. The general consensus is that liver resection should be the treatment of choice in patients with good liver function while local ablation should be considered in patients with poor liver function. There exists a group of patients with apparently good liver function that harbor significant liver cirrhosis which is not easily picked up by the current assessment or scoring systems. Liver resection in this group of patients is burdened by potentially life-threatening complications and the overall survival is limited by their underlying liver cirrhosis. This is particularly important in early HCC as local ablation is another curative treatment option. In order to improve the prognosis of patients with early HCC, it is important to identify (1) patients with liver dysfunction to the extend that the risk of liver resection will outweigh the survival benefit it provides; (2) the best ablative method for HCC.

The investigators propose to carry out a prospective randomized controlled study to compare the treatment outcome of microwave ablation with liver resection in patients with borderline liver function whose HCC that are amendable to both liver resection and microwave ablation.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* HCC amendable for both MWA and liver resection
* Liver function of ALBI Grade 2
* Tumour size \</= 5cm
* Absence of extrahepatic metastasis
* Absence of radiology evidence of major vascular or bile duct invasion

Exclusion Criteria:

* Informed consent not available
* Patients with ALBI 3, Child-Pugh B or above
* Multifocal tumour
* Presence of portal vein or hepatic artery thrombosis
* Anticipation of concomitant procedures
* Emergency hepatectomy
* Ruptured HCC
* Patients with chronic renal failure
* Pregnant female patients

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 5 years
measure: Recurrence rate
timeFrame: 5 years
measure: Morbidity rate
timeFrame: 1 year
measure: Hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Charing CN Chong, MBChB
role: PRINCIPAL_INVESTIGATOR
References: