NCT01340105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

5.9 years

First QC Date

April 19, 2011

Last Update Submit

March 5, 2022

Conditions

Hepatocellular Carcinoma

Keywords

Microwave ablationRadiofrequency ablationRandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Complete ablation rate

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

    1 month

Secondary Outcomes (6)

  • Treatment related mortality

    30-day

  • Recurrent disease

    3 year

  • Survival

    3 year

  • Long-term liver function

    3 year

  • Treatment related morbidity

    30-day

  • +1 more secondary outcomes

Study Arms (2)

Microwave

EXPERIMENTAL

Hepatocellular carcinoma treated with microwave ablation

Procedure: Microwave ablation

Radiofrequency

ACTIVE COMPARATOR

Hepatocellular carcinoma treated with radiofrequency ablation

Procedure: Radiofrequency ablation

Interventions

Microwave ablationPROCEDURE

Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Microwave
Radiofrequency ablationPROCEDURE

Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.

Radiofrequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Kit-fai Lee, MBBS

    Department of Surgery, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

April 19, 2011

First Posted

April 22, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)