Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer (LiverMWA1)

November 13, 2009 updated by: University Hospital, Gasthuisberg

Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible

Microwave ablation (MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate the variability and reproducibility of single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller than 3 cm in patients without underlying liver disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospital Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unresectable metastatic liver cancer
  • No invasion of major biliary structures
  • No invasion of major vascular structures
  • ASA score < 4
  • WHO score 0-1
  • Pre-operative chemotherapy is allowed

Exclusion Criteria:

  • Resectable liver metastases
  • Life expectancy less than 3 months
  • Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials
  • Coagulopathy with platelet count less than 50000
  • Active infectious disease
  • Age below 18 years
  • Pregnancy of breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MWA
Patients undergoing MWA for hepatic metastases smaller than 3 cm, without underlying liver disease
Device: Microwave ablation
Liver tumors are destructed/ablated using single-probe microwave energy device
Other Names:
  • MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)
Active Comparator: RFA
Patients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease
Device: Radiofrequency ablation
Liver tumors are destructed/ablated using radiofrequency energy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variability of ablation diameters
Time Frame: within the first 7 days and 3 months after surgery
within the first 7 days and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Baki Topal, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2009

Last Update Submitted That Met QC Criteria

November 13, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kulasMWA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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