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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microwave ablation
Radiofrequency ablation
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Microwave ablation, Radiofrequency ablation, Randomised controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microwave

Radiofrequency

Arm Description

Hepatocellular carcinoma treated with microwave ablation

Hepatocellular carcinoma treated with radiofrequency ablation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment related mortality
Mortality within 30 days after operation
Recurrent disease
It is defined as the imaging detected new lesions
Survival
Overall and disease-free survival
Long-term liver function
Monitoring of liver function test result and the occurrance of decompensated cirrhosis
Treatment related morbidity
Complications related to the treatment received
Hospital stay
Total length of hospital stay (days)

Full Information

First Posted
April 19, 2011
Last Updated
March 5, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01340105
Brief Title
Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation
Official Title
Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Microwave ablation, Radiofrequency ablation, Randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microwave
Arm Type
Experimental
Arm Description
Hepatocellular carcinoma treated with microwave ablation
Arm Title
Radiofrequency
Arm Type
Active Comparator
Arm Description
Hepatocellular carcinoma treated with radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
Primary Outcome Measure Information:
Title
Complete ablation rate
Description
Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Treatment related mortality
Description
Mortality within 30 days after operation
Time Frame
30-day
Title
Recurrent disease
Description
It is defined as the imaging detected new lesions
Time Frame
3 year
Title
Survival
Description
Overall and disease-free survival
Time Frame
3 year
Title
Long-term liver function
Description
Monitoring of liver function test result and the occurrance of decompensated cirrhosis
Time Frame
3 year
Title
Treatment related morbidity
Description
Complications related to the treatment received
Time Frame
30-day
Title
Hospital stay
Description
Total length of hospital stay (days)
Time Frame
30-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kit-fai Lee, MBBS
Organizational Affiliation
Department of Surgery, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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