Clinical trial NCT03981497: Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Liver Metastasis Colon Cancer
Kidney Cancer
Renal Cell Carcinoma
Keywords: MWA
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with indication of laparoscopic or percutaneous ablation of primary or secondary liver tumors and small primary kidney tumors (according to ESMO guidelines).

All patients will follow their normal therapeutic procedure and no examination will be added to what is already provided for in the normal management of patients suffering from these diseases.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local Tumor Progression Free Survival
timeFrame: From date of ablation until death from any cause; evaluated up to 5 years
measure: Time to Local Progression
timeFrame: From date of ablation until death from any cause; evaluated up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of ablation until death from any cause; evaluated up to 5 years
measure: Progression Free Survival (PFS)
timeFrame: From date of ablation until death from any cause; evaluated up to 5 years
measure: Organ specific Progression Free Survival (PFS)
timeFrame: From date of ablation until death from any cause; evaluated up to 5 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
citation: De Cobelli F, Marra P, Ratti F, Ambrosi A, Colombo M, Damascelli A, Sallemi C, Gusmini S, Salvioni M, Diana P, Cipriani F, Venturini M, Aldrighetti L, Del Maschio A. Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art. Med Oncol. 2017 Apr;34(4):49. doi: 10.1007/s12032-017-0903-8. Epub 2017 Feb 20.