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

Francesco De Cobelli

Status: Enrolling

Conditions: Kidney Cancer; Renal Cell Carcinoma; Liver Metastasis Colon Cancer; Liver Cancer

Treatments: Procedure: Microwave ablation (MWA)

Study type: Observational

Funder types: Other

Identifiers

NCT03981497

MWA-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Small Renal Tumors

Description:

Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA

Treatment:

Procedure: Microwave ablation (MWA)

Primary and Secondary Liver cancer

Description:

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

Treatment:

Procedure: Microwave ablation (MWA)