Mikrobølgeablasjon for behandling av små nyresvulster og primære og sekundære leverneoplasmer
Retrospektiv og perspektivanalyse av kort, middels og langvarig klinisk ytelse hos pasienter som gjennomgår mikrobølgetermisk ablasjon for behandling av små nyresvulster 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Francesco De Cobelli, MD
- Telefonnummer: +390226432529
- E-post: decobelli.francesco@hsr.it
Studer Kontakt Backup
- Navn: Stephanie Steidler, PhD
- Telefonnummer: +3926432529
- E-post: steidler.stephanie@hsr.it
Studiesteder
-
-
-
Milan, Italia, 20153
- Rekruttering
- IRCCS Ospedale San Raffaele
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Ta kontakt med:
- Francesco De Cobelli
- E-post: decobelli.francesco@hsr.it
-
Ta kontakt med:
- Stephanie Steidler, PhD
- Telefonnummer: +390226432529
- E-post: steidler.stephanie@hsr.it
-
Underetterforsker:
- Paolo Marra, MD
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Underetterforsker:
- Michele Colombo, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Neoplasmer etter histologisk type
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Urologiske neoplasmer
- Karsinom
- Neoplasmer i leveren
- Karsinom, nyrecelle
- Nyre-neoplasmer
Andre studie-ID-numre
- MWA-01
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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