Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

I.M. Sechenov First Moscow State Medical University

Status: Enrolling

Conditions: Renal Tumor

Treatments: Procedure: Cryoablation; Procedure: Renal biopsy; Procedure: Partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04506671

CA_vs_PN

Details and patient eligibility

About

The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

•CT-confirmed renal mass > 4 to 7 cm (T1b)

Exclusion criteria

• Multiple renal tumors;
• Recurrence of renal tumor;
• Intolerance to iodine-containing contrast agents;
• Pregnancy;
• Patients with Bosniak 4 cysts
• Presence of other oncological diseases;
• Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system
• Absence of malignant pathology based on prior biopsy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Cryoablation group

Experimental group

Description:

Patients with T1b renal tumor and ECOQ\>20

Treatment:

Procedure: Cryoablation

Procedure: Renal biopsy

Partial nephrectomy group

Active Comparator group

Description:

Patients with T1b renal tumor

Treatment:

Procedure: Partial nephrectomy