Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Study Overview
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Brief Summary
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The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA. Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path

Detailed Description
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Observational, retrospective and prospective, monocentric study. The objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (MWA) for small renal tumors and primary and secondary liver neoplasms. Evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.At the end of the follow-up periods, the data collected will be compared with those available in the literature on MWA, cryoablation (CA), radiofrequency ablation (RFA) and surgical resection.

Official Title
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Retrospective and Perspective Analysis of Short, Medium and Long Term Clinical Performance of Patients Undergoing MicrowaveThermal Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Conditions
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Liver Metastasis Colon Cancer, Kidney Cancer, Liver Cancer, Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: Microwave ablation (MWA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone Primary liver cancer: up to three liver nodules ≤ 3 cm Secondary hepatic tumours: up to nodules ≤ 3 cm provided that the objective is complete hepatic clearance Renal tumours: single or multiple (von Hippel Lindau syndrome), < 4 cm Exclusion Criteria: pregnant women non-manageable coagulopathies Extended extrahepatic or extrarenal disease for liver ablation: presence of bilio-digestive anastomosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Small Renal Tumors<br>Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA | Procedure: Microwave ablation (MWA)<br>* Thermal ablation<br>|
| Primary and Secondary Liver cancer<br>Primary liver tumors: subjects who are candidates for MWA with nodules ≤ 3 cm Liver metastases: subjects who are candidates for MWA with nodules less than ≤ 3 cm | Procedure: Microwave ablation (MWA)<br>* Thermal ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tumor Progression Free Survival | Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins) | From date of ablation until death from any cause; evaluated up to 5 years | 
| Time to Local Progression | Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins) | From date of ablation until death from any cause; evaluated up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | From date of ablation until death for any cause | From date of ablation until death from any cause; evaluated up to 5 years | 
| Progression Free Survival (PFS) | From date of ablation until any documented evidence of tumor progression at any site | From date of ablation until death from any cause; evaluated up to 5 years | 
| Organ specific Progression Free Survival (PFS) | From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site) | From date of ablation until death from any cause; evaluated up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MWA