- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922181
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
-
-
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
|
Liver tumors are destructed/ablated using single-probe microwave energy device
Other Names:
|
Active Comparator: RFA
Patients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease
|
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.
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.
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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