Mikrobølgeablation til behandling af små nyretumorer og primære og sekundære leverneoplasmer
Retrospektiv og perspektivisk analyse af kort-, mellem- og langtids klinisk ydeevne hos patienter, der gennemgår mikrobølgetermisk ablation til behandling af små nyretumorer og primære og sekundære leverneoplasmer
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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Francesco De Cobelli, MD
- Telefonnummer: +390226432529
- E-mail: decobelli.francesco@hsr.it
Undersøgelse Kontakt Backup
- Navn: Stephanie Steidler, PhD
- Telefonnummer: +3926432529
- E-mail: steidler.stephanie@hsr.it
Studiesteder
-
-
-
Milan, Italien, 20153
- Rekruttering
- IRCCS Ospedale San Raffaele
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Kontakt:
- Francesco De Cobelli
- E-mail: decobelli.francesco@hsr.it
-
Kontakt:
- Stephanie Steidler, PhD
- Telefonnummer: +390226432529
- E-mail: steidler.stephanie@hsr.it
-
Underforsker:
- Paolo Marra, MD
-
Underforsker:
- Michele Colombo, MD
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Small Renal Tumors
Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA |
Thermal ablation |
|
Primary and Secondary Liver cancer
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 |
Thermal ablation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Local Tumor Progression Free Survival
Tidsramme: 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) |
From date of ablation until death from any cause; evaluated up to 5 years
|
|
Time to Local Progression
Tidsramme: 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) |
From date of ablation until death from any cause; evaluated up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: From date of ablation until death from any cause; evaluated up to 5 years
|
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)
Tidsramme: 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 |
From date of ablation until death from any cause; evaluated up to 5 years
|
|
Organ specific Progression Free Survival (PFS)
Tidsramme: 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) |
From date of ablation until death from any cause; evaluated up to 5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- di Gaeta E, Olivieri M, Savi A, Magnani P, Canevari C, Gusmini S, Palumbo D, Guazzarotti G, Augello L, Calabrese F, Steidler S, Cipriani F, Rimini M, Casadei-Gardini A, Aldrighetti L, Chiti A, De Cobelli F. Radioembolization for Hepatocellular Carcinoma: a Comparison on Dual-phase Cone-beam CT, Contrast-enhanced CT (CECT) and 99mTc-macroaggregated albumin-SPECT/CT in predicting final distribution volumes and dosimetry of the post-embolization 90Y PET/CT. Radiol Med. 2025 Apr;130(4):474-485. doi: 10.1007/s11547-024-01946-0. Epub 2024 Dec 20.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Urologiske neoplasmer
- Karcinom
- Neoplasmer i leveren
- Karcinom, nyrecelle
- Nyre-neoplasmer
Andre undersøgelses-id-numre
- MWA-01
Plan for individuelle deltagerdata (IPD)
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