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出境医 / 临床实验 / Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Liver Cancer Liver Metastasis Colon Cancer Kidney Cancer Renal Cell Carcinoma | Procedure: Microwave ablation (MWA) |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 250 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| 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 |
| Actual Study Start Date : | February 28, 2018 |
| Estimated Primary Completion Date : | February 28, 2024 |
| Estimated Study Completion Date : | February 28, 2024 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Procedure: Microwave ablation (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
|
Procedure: Microwave ablation (MWA)
Thermal ablation
|
Outcome Measures
Primary Outcome Measures :
- Local Tumor Progression Free Survival [ Time Frame: 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 [ Time Frame: 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 Outcome Measures :
- Overall Survival (OS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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
Contacts and Locations
Contacts
| Contact: Francesco De Cobelli, MD | +390226432529 | decobelli.francesco@hsr.it | |
| Contact: Stephanie Steidler, PhD | +3926432529 | steidler.stephanie@hsr.it |
Locations
| Italy | |
| IRCCS Ospedale San Raffaele | Recruiting |
| Milano, Italy, 20153 | |
| Contact: Francesco De Cobelli decobelli.francesco@hsr.it | |
| Contact: Stephanie Steidler, PhD +390226432529 steidler.stephanie@hsr.it | |
| Sub-Investigator: Paolo Marra, MD | |
| Sub-Investigator: Michele Colombo, MD | |
Sponsors and Collaborators
Francesco De Cobelli
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 27, 2019 | ||||||||
| First Posted Date | June 10, 2019 | ||||||||
| Last Update Posted Date | February 10, 2021 | ||||||||
| Actual Study Start Date | February 28, 2018 | ||||||||
| Estimated Primary Completion Date | February 28, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| Brief Summary | 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition |
|
||||||||
| Intervention | Procedure: Microwave ablation (MWA)
Thermal ablation
|
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| Study Groups/Cohorts |
|
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| Publications * | 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. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
250 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | February 28, 2024 | ||||||||
| Estimated Primary Completion Date | February 28, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Italy | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03981497 | ||||||||
| Other Study ID Numbers | MWA-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Francesco De Cobelli, IRCCS San Raffaele | ||||||||
| Study Sponsor | Francesco De Cobelli | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | IRCCS San Raffaele | ||||||||
| Verification Date | February 2021 | ||||||||
