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

Primary Purpose

Liver Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Microwave ablation
Radiofrequency ablation
Sponsored by
University Hospital, Gasthuisberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring malignancy, liver, microwave, surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MWA

RFA

Arm Description

Patients undergoing MWA for hepatic metastases smaller than 3 cm, without underlying liver disease

Patients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease

Outcomes

Primary Outcome Measures

Variability of ablation diameters

Secondary Outcome Measures

Full Information

First Posted
June 1, 2009
Last Updated
November 13, 2009
Sponsor
University Hospital, Gasthuisberg
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1. Study Identification

Unique Protocol Identification Number
NCT00922181
Brief Title
Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer
Acronym
LiverMWA1
Official Title
Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gasthuisberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
malignancy, liver, microwave, surgery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
MWA
Arm Type
Experimental
Arm Description
Patients undergoing MWA for hepatic metastases smaller than 3 cm, without underlying liver disease
Arm Title
RFA
Arm Type
Active Comparator
Arm Description
Patients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease
Intervention Type
Device
Intervention Name(s)
Microwave ablation
Other Intervention Name(s)
MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)
Intervention Description
Liver tumors are destructed/ablated using single-probe microwave energy device
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation
Intervention Description
Liver tumors are destructed/ablated using radiofrequency energy device
Primary Outcome Measure Information:
Title
Variability of ablation diameters
Time Frame
within the first 7 days and 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baki Topal, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
20605397
Citation
Hompes R, Fieuws S, Aerts R, Thijs M, Penninckx F, Topal B. Results of single-probe microwave ablation of metastatic liver cancer. Eur J Surg Oncol. 2010 Aug;36(8):725-30. doi: 10.1016/j.ejso.2010.05.013. Epub 2010 Jun 3.
Results Reference
derived

Learn more about this trial

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

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