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

Liver Neoplasms Clinical Trial

— LiverMWA1  

Official title:

Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922181
• Other study ID #: kulasMWA1
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: November 13, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: November 2009
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Device:
• Microwave ablation
Liver tumors are destructed/ablated using single-probe microwave energy device
• Radiofrequency ablation
Liver tumors are destructed/ablated using radiofrequency energy device

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of ablation diameters		within the first 7 days and 3 months after surgery	No