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

Completed

• Conditions: Renal Cell Cancer

• Registration Number: NCT06829888
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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).

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2024-12
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 955

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size.	between January 2007 and July 2019	No 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 Outcome Measures

Name	Time	Method
Secondary outcome was death due to cause other than RCC (OCM)	between January 2007 and July 2019	RCC 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.