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

Not Applicable

Recruiting

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: Liver resection; Procedure: Microwave ablation

• Registration Number: NCT03766555
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liver Resection	Liver resection	Liver resection will be performed in patients randomized to this arm.
Microwave Ablation	Microwave ablation	Microwave ablation (MWA) will be performed in patients randomized to this arm.

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	The primary outcome of this study is the overall survival

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	5 years	Liver cancer recurrence rate
Disease-free survival	5 years	Disease-free survival
Hospital stay	1 year	Hospital length of stay
Morbidity rate	1 year	Morbidity rate

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong