ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00922181
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : November 16, 2009
Sponsor:
Information provided by:
University Hospital, Gasthuisberg

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.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Device: Microwave ablation Device: Radiofrequency ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible
Study Start Date : August 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Variability of ablation diameters [ Time Frame: within the first 7 days and 3 months after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009

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

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