Clinical trial NCT06829888: Percutaneous Tumor Ablation Vs Partial Nephrectomy for Small Renal Mass: the Impact of Histologic Variant and Tumor Size
Official title: Percutaneous Tumor Ablation Versus Partial Nephrectomy for Small Renal Mass: the Impact of Histologic Variant and Tumor Size
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Keywords: Kidney neoplasms
Nephrectomy
Radiofrequency ablation
Cryosurgery
Recurrence
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 955
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from 955 consecutive patients Were retrospectively selected with clinically localized (cN0 M0) renal mass (cT1) treated with PN or percutaneous RFA or percutaneous Cryo between January 2007 and July 2019.

During preoperative workout, each patient performed either with abdominal and chest contrast enhanced computed tomography or magnetic resonance imaging to stage the disease. Tumor's complexity was defined according to PADUA score.11 Overall, 139 (14.6%) patients were excluded due to incomplete clinical data (Charlson Comorbidity Index \[CCI\], PADUA Score, clinical size of the tumor and age were lacking in 105 \[10.9%\], 75 \[7.8%\], 2 \[0.2%\] and2 \[0.2%\] patients, respectively), resulting in a final population of 816 individuals treated with PN (N.=665), RFA (N.=68) or Cryo (N.=83).

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: 1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size.
timeFrame: between January 2007 and July 2019
Secondary outcomes:
measure: Secondary outcome was death due to cause other than RCC (OCM)
timeFrame: between January 2007 and July 2019
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Lorenzo Bianchi, MD
role: PRINCIPAL_INVESTIGATOR
References: