Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Carcinoma, Hepatocellular

Treatments: Procedure: Liver resection; Procedure: Microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03766555

2016.205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Microwave Ablation

Experimental group

Description:

Microwave ablation (MWA) will be performed in patients randomized to this arm.

Treatment:

Procedure: Microwave ablation

Liver Resection

Active Comparator group

Description:

Liver resection will be performed in patients randomized to this arm.

Treatment:

Procedure: Liver resection