Liver NeoplasmsLiverMWA1NCT00922181
Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer
A study testing Microwave ablation and Radiofrequency ablation in people with Liver Neoplasms, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Microwave ablation and Radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Liver Neoplasms
- Being tested
- Microwave ablation, Radiofrequency ablation
- Keywords
- malignancy, liver, microwave, surgery
- Medical subject headings
- Liver Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationDevice
Also called MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)
Liver tumors are destructed/ablated using single-probe microwave energy device
Radiofrequency ablationDevice
Liver tumors are destructed/ablated using radiofrequency energy device
| Study group | Role | What they receive |
|---|---|---|
| MWA | Experimental | Patients undergoing MWA for hepatic metastases smaller than 3 cm, without underlying liver disease Receives: Device: Microwave ablation |
| RFA | Active comparator | Patients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of ablation diameters
Measured: within the first 7 days and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Baki Topal, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922181
- Sponsor's protocol ID
- kulasMWA1
- Acronym
- LiverMWA1
- Status last verified
- Nov 2009
- First submitted
- 1 Jun 2009
- Last updated
- 16 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20605397
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible
- ClinicalTrials.gov ID
- NCT00922181
- Acronym / sponsor ID
- LiverMWA1 / kulasMWA1
- Conditions
- Liver Neoplasms
- Keywords
- malignancy, liver, microwave, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWA | Experimental | Device: Microwave ablationPatients undergoing MWA for hepatic metastases smaller than 3 cm, without underlying liver disease |
| RFA | Active comparator | Device: Radiofrequency ablationPatients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unresectable metastatic liver cancer
- No invasion of major biliary structures
- No invasion of major vascular structures
- ASA score < 4
- WHO score 0-1
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablationAlso: MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)Liver tumors are destructed/ablated using single-probe microwave energy device | Device | MWA |
| Radiofrequency ablationLiver tumors are destructed/ablated using radiofrequency energy device | Device | RFA |
Primary outcome
Variability of ablation diameters
Time frame: within the first 7 days and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2009.
- Derived from this study: PubMed 20605397Hompes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baki Topal, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation and Radiofrequency ablation in people with Liver Neoplasms, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of ablation diameters (time frame: within the first 7 days and 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00922181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2009.