Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Tumor
• Intervention / Treatment: Procedure: Renal biopsy; Procedure: Cryoablation; Procedure: Partial nephrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Institute for Urology and Reproductive Health, Sechenov University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoablation group; Patients with T1b renal tumor and ECOQ>20	Procedure: Renal biopsy; Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols; Procedure: Cryoablation; Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
Active Comparator: Partial nephrectomy group; Patients with T1b renal tumor	Procedure: Partial nephrectomy; Partial nephrectomy will be performed on the basis of the center and according to the current protocols

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Anticipated): May 22, 2025
• Study Completion (Anticipated): June 22, 2025

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Cryoablation; Renal cancer; Partial nephrectomy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: CA_vs_PN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No