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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT01340105
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 2
• Actual Duration (Months): 83
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Microwave ablation; Procedure: Radiofrequency ablation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial
• Actual Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microwave Hepatocellular carcinoma treated with microwave ablation	Procedure: Microwave ablation; Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
Active Comparator: Radiofrequency Hepatocellular carcinoma treated with radiofrequency ablation	Procedure: Radiofrequency ablation; Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Outcome Measures

Primary Outcome Measures

1. Complete ablation rate [1 month]

   Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)

Secondary Outcome Measures

1. Treatment related mortality [30-day]

   Mortality within 30 days after operation

2. Recurrent disease [3 year]

   It is defined as the imaging detected new lesions

3. Survival [3 year]

   Overall and disease-free survival

4. Long-term liver function [3 year]

   Monitoring of liver function test result and the occurrance of decompensated cirrhosis

5. Treatment related morbidity [30-day]

   Complications related to the treatment received

6. Hospital stay [30-day]

   Total length of hospital stay (days)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Hong Kong		China

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

• Principal Investigator: Kit-fai Lee, MBBS, Department of Surgery, The Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cheung Yue Sun, Associate Consultant, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01340105
• Other Study ID Numbers: CT11005
• First Posted: Apr 22, 2011
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Cheung Yue Sun, Associate Consultant, Chinese University of Hong Kong: Microwave ablation; Radiofrequency ablation; Randomised controlled trial
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 21, 2022