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Spots Global Cancer Trial Database for Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Intrahepatic Vessels

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Trial Identification

Brief Title: Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Intrahepatic Vessels

Official Title: To Evaluate the Safety and Efficacy of Microwave Ablation for the Treatment of Malignant

Study ID: NCT03063840

Conditions

Liver Cancer

Interventions

Microwave ablation

Study Description

Brief Summary: Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.

Detailed Description: Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Emprint Microwave Ablation system) with 2.45 GHz microwave generator the investigators will use has been approved as safe by the European Union (EU) in 2009 and received Food and Drug Administration (FDA) approval in 2014. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 40 inoperable patients with liver cancers adjacent to vessels who are suitable to receive radiofrequency ablation (RFA) in our hospital. The investigators will evaluate the potential side effect and ablate effect of tumors by abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators will also follow-up this patients for 1 years to evaluate the overall survival and local recurrence rate. The investigators will appraisal the clinical feasibility and advantage of the system by this study.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Kai-Wen Huang, PhD

Affiliation: National Taiwan University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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