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

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).

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Key information

Conditions

Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size.

Time frame: 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 outcomes

Secondary outcome was death due to cause other than RCC (OCM)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: CRYO-BO-2021

Important dates

Study start: 2007
Primary completion: 2019
Study completion: 2019
First posted: Feb 17, 2025
Registry last updated: Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed