Percutaneous Tumor Ablation Vs Partial Nephrectomy for Small Renal Mass: the Impact of Histologic Variant and Tumor Size

NCT ID: NCT06829888

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

955 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2019-07-01

Brief Summary

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The aim, of this study is to investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo).

Detailed Description

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The aim of our study was to compare oncologic outcomes in terms of recurrence and competing causes of mortality in patients undergone either PN, radiofrequency ablation (RFA) or cryoablation (Cryo) focusing on tumor volume and histologic variant. Retrospectively were evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent PN, RFA and Cryo, respectively. Kaplan-Meier curves depict recurrence-free survival (RFS) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell RCC and non-clear RCC) and size (namely \<2 cm and 2-4 cm). Multivariable Cox regression model was used to identify predictors of recurrence. Cumulative-incidence plots evaluated disease recurrence and other causes of mortality (OCM).

Conditions

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Renal Cell Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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localized (cN0 M0) renal mass (cT1) treated with partial nephrectomy

patients with clinically localized (cN0 M0) renal mass (cT1) treated with partial nephrectomy

No interventions assigned to this group

localized (cN0 M0) renal mass (cT1) treated with percutaneus RFA

patients with clinically localized (cN0 M0) renal mass (cT1) treated with percutaneus RFA

No interventions assigned to this group

localized (cN0 M0) renal mass (cT1) treated with percutaneous cryo

patients with clinically localized (cN0 M0) renal mass (cT1) treated with percutaneous cryo

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Radiologic diagnosis (CT chest-abdomen or MRI abdomen with contrast medium) of renal neoplasm
* Renal neoplasm of clinical stage T1a (≤4 cm) N0M0
* Age \>18 years
* Informed consent
* Absence of other neoplasm

Exclusion Criteria

* Patients refuse partial nephrectomy and/or percutaneous renal CA and are candidates for active surveillance
* Patients who are candidates for radical nephrectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorenzo Bianchi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other Identifiers

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CRYO-BO-2021

Identifier Type: -

Identifier Source: org_study_id

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