NCT00922181

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

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

August 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

November 16, 2009

Status Verified

November 1, 2009

Enrollment Period

8 months

First QC Date

June 1, 2009

Last Update Submit

November 13, 2009

Conditions

Keywords

malignancylivermicrowavesurgery

Outcome Measures

Primary Outcomes (1)

  • Variability of ablation diameters

    within the first 7 days and 3 months after surgery

Study Arms (2)

MWA

EXPERIMENTAL

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

Device: Microwave ablation

RFA

ACTIVE COMPARATOR

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

Device: Radiofrequency ablation

Interventions

Liver tumors are destructed/ablated using single-probe microwave energy device

Also known as: MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)
MWA

Liver tumors are destructed/ablated using radiofrequency energy device

RFA

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Liver NeoplasmsNeoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Baki Topal, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 17, 2009

Study Start

August 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

November 16, 2009

Record last verified: 2009-11

Locations