Microgolfablatie voor de behandeling van kleine niertumoren en primaire en secundaire leverneoplasmata
Retrospectieve en perspectiefanalyse van klinische prestaties op korte, middellange en lange termijn van patiënten die microgolfthermische ablatie ondergaan voor de behandeling van kleine niertumoren en primaire en secundaire leverneoplasmata
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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Francesco De Cobelli, MD
- Telefoonnummer: +390226432529
- E-mail: decobelli.francesco@hsr.it
Studie Contact Back-up
- Naam: Stephanie Steidler, PhD
- Telefoonnummer: +3926432529
- E-mail: steidler.stephanie@hsr.it
Studie Locaties
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Milan, Italië, 20153
- Werving
- IRCCS Ospedale San Raffaele
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Contact:
- Francesco De Cobelli
- E-mail: decobelli.francesco@hsr.it
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Contact:
- Stephanie Steidler, PhD
- Telefoonnummer: +390226432529
- E-mail: steidler.stephanie@hsr.it
-
Onderonderzoeker:
- Paolo Marra, MD
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Onderonderzoeker:
- Michele Colombo, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: CROSS_SECTIONAL
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Local Tumor Progression Free Survival
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Neoplasmata per histologisch type
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Urologische neoplasmata
- Carcinoom
- Lever neoplasmata
- Carcinoom, niercel
- Nierneoplasmata
Andere studie-ID-nummers
- MWA-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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