Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

Study Overview
=================
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.

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

Conditions
-----------------
Renal Tumor

Intervention / Treatment
-----------------
* Procedure: Renal biopsy
* Procedure: Cryoablation
* Procedure: Partial nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryoablation, Renal cancer, Partial nephrectomy