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

NCT ID: NCT00922181

Last Updated: 2009-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MWA

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

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type DEVICE

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

RFA

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

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type DEVICE

Liver tumors are destructed/ablated using radiofrequency energy device

Interventions

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Microwave ablation

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

Intervention Type DEVICE

Radiofrequency ablation

Liver tumors are destructed/ablated using radiofrequency energy device

Intervention Type DEVICE

Other Intervention Names

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MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Principal Investigators

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Baki Topal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospital Gasthuisberg

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 20605397 (View on PubMed)

Other Identifiers

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kulasMWA1

Identifier Type: -

Identifier Source: org_study_id

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