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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00922181
First received: June 1, 2009
Last updated: November 13, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Liver Neoplasms
 Device: Microwave ablation
Device: Radiofrequency ablation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Variability of ablation diameters [ Time Frame: within the first 7 days and 3 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922181

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Baki Topal, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided by University Hospital, Gasthuisberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital Gasthuisberg Leuven
ClinicalTrials.gov Identifier: NCT00922181     History of Changes
Other Study ID Numbers: kulasMWA1
Study First Received: June 1, 2009
Last Updated: November 13, 2009
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by University Hospital, Gasthuisberg:
malignancy
liver
microwave
surgery

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013