Kidney Cancer, Liver Cancer, Liver Metastasis Colon Cancer, Renal Cell Carcinoma
Conditions
Keywords
MWA
Brief summary
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
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.
Interventions
PROCEDUREMicrowave ablation (MWA)
Thermal ablation
Sponsors
Francesco De Cobelli
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Progression Free Survival | From date of ablation until death from any cause; evaluated up to 5 years | Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins) |
| Time to Local Progression | From date of ablation until death from any cause; evaluated up to 5 years | Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of ablation until death from any cause; evaluated up to 5 years | From date of ablation until death for any cause |
| Progression Free Survival (PFS) | From date of ablation until death from any cause; evaluated up to 5 years | From date of ablation until any documented evidence of tumor progression at any site |
| Organ specific Progression Free Survival (PFS) | From date of ablation until death from any cause; evaluated up to 5 years | From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site) |
Countries
Italy
Contacts
Primary ContactFrancesco De Cobelli, MD
Backup ContactStephanie Steidler, PhD
Outcome results
None listed