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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06829888
Acronym
CRYO-BO-2021
Enrollment
955
Registered
2025-02-17
Start date
2007-01-01
Completion date
2019-07-01
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Cancer

Keywords

Kidney neoplasms, Nephrectomy, Radiofrequency ablation, Cryosurgery, Recurrence

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).

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size.between January 2007 and July 2019No significant differences were recorded concerning the tumor's histology between the three groups. Patient follow-up for ablation was recommended at 3 months with abdominal CEUS and at 6 and 12 months with abdominal and chest CT or MRI followed by yearly intervals. In case of PN, the scheduled follow up included abdominal US at 6 months and abdominal and chest CT or MRI at 12 months, followed by two-yearly intervals. Local recurrence following ablation was defined as new focal enhancement in the ablation bed or enlargement of the ablation defect on follow-up imaging. Local recurrence following PN was defined as a mass in the ipsilateral kidney. Occurrence of metastatic disease was defined as extrarenal disseminated disease, with or without pathologic confirmation. Patients treated with PN experience better RFS rates as compared to both ablative techniques.However, considering patients with non-ccRCC and those with renal mass \< 2cm, both PN and Cryo are valid options.

Secondary

MeasureTime frameDescription
Secondary outcome was death due to cause other than RCC (OCM)between January 2007 and July 2019RCC was considered as the cause of death when it was registered as the first cause on death certificate, otherwise OCM was considered as the cause of death.PN proved to achieve better oncologic and survival outcomes compared to RFA and Cryo, since 91.2% vs. 67.8% and 60.2% of cases would be free from recurrence and OCM, respectively.These findings are mainly due to higher proportion of aged patients with shorter life expectancy in RFA and Cryo group than PN.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026