Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation

Hepatocellular Carcinoma Clinical Trial

Official title:

Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340105
• Other study ID #: CT11005
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: March 2018

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Microwave ablation
Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
• Radiofrequency ablation
Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete ablation rate	Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)	1 month
Secondary	Treatment related mortality	Mortality within 30 days after operation	30-day
Secondary	Recurrent disease	It is defined as the imaging detected new lesions	3 year
Secondary	Survival	Overall and disease-free survival	3 year
Secondary	Long-term liver function	Monitoring of liver function test result and the occurrance of decompensated cirrhosis	3 year
Secondary	Treatment related morbidity	Complications related to the treatment received	30-day
Secondary	Hospital stay	Total length of hospital stay (days)	30-day