Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

Not Applicable

Recruiting

• Conditions: Renal Tumor
• Interventions: Procedure: Renal biopsy; Procedure: Partial nephrectomy; Procedure: Cryoablation

• Registration Number: NCT04506671
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-22
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-28
• Primary Completion: 2025-05-22
• Study Completion: 2025-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation group	Renal biopsy	Patients with T1b renal tumor and ECOQ\>20
Partial nephrectomy group	Partial nephrectomy	Patients with T1b renal tumor
Cryoablation group	Cryoablation	Patients with T1b renal tumor and ECOQ\>20

Primary Outcome Measures

Name	Time	Method
Local recurrence	5 years	Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment

Secondary Outcome Measures

Name	Time	Method
Metastatic progression	5 years	Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Blood loss	12 months	Pre- and postoperative Hb level
Length of hospital stay	1 month	Number of days spent in hospital
Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)	5 years	Quality of life will be assessed using scales EORTC QLQ C-30, ranging from 1 to 100, where higher score indicating a better Quality of Life
Pain score	5 years	Pain score will be assessed using visual analogue scale
Renal function	5 years	Renal function will be evaluated with eGFR
Rate of adverse events	3 months	Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system

Trial Locations

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University.; 🇷🇺 Moscow, Russian Federation