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

NCT06829888 | Completed

• 1 other identifier: CRYO-BO-2021
• Study Type: observational
• Target: 955
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Renal Cell Cancer

Keywords

Kidney neoplasms; Nephrectomy; Radiofrequency ablation; Cryosurgery; Recurrence

Outcome Measures

Primary Outcomes (1)

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

  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.

  between January 2007 and July 2019

Secondary Outcomes (1)

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

  between January 2007 and July 2019

Study Arms (3)

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Patients refuse partial nephrectomy and/or percutaneous renal CA and are candidates for active surveillance
• Patients who are candidates for radical nephrectomy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Lorenzo Bianchi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 17, 2025
• Study Start: January 1, 2007
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 17, 2025

Record last verified: 2024-12