Hepatocellular Carcinoma
Conditions
Keywords
Microwave ablation, Radiofrequency ablation, Randomised controlled trial
Brief summary
The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC). The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation. A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.
Interventions
PROCEDUREMicrowave ablation
Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
PROCEDURERadiofrequency ablation
Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Unresectable hepatocellular carcinoma (HCC) and tumor amendable for local ablation * Resectable HCC but patient opts for local ablation * Maximum diameter of tumor ≤6cm * Maximum number of tumor nodules ≤3 * Absence of radiology evidence of major vascular or bile duct invasion * Child's A or B liver function * Karnofsky performance status ≥70%
Exclusion criteria
* Informed consent not available * Pregnant female patients * Tumors unfavourable for local ablation (e.g. tumor close to porta hepatis) * HCC with history of rupture * Concomitant hepatectomy * Patients with chronic renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete ablation rate | 1 month | Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent disease | 3 year | It is defined as the imaging detected new lesions |
| Survival | 3 year | Overall and disease-free survival |
| Treatment related mortality | 30-day | Mortality within 30 days after operation |
| Treatment related morbidity | 30-day | Complications related to the treatment received |
| Hospital stay | 30-day | Total length of hospital stay (days) |
| Long-term liver function | 3 year | Monitoring of liver function test result and the occurrance of decompensated cirrhosis |
Countries
China
Outcome results
None listed