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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
Partial nephrectomy will be performed on the basis of the center and according to the current protocols
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
RECRUITINGLocal recurrence
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Time frame: 5 years
Metastatic progression
Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Time frame: 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
Time frame: 5 years
Renal function
Renal function will be evaluated with eGFR
Time frame: 5 years
Rate of adverse events
Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system
Time frame: 3 months
Blood loss
Pre- and postoperative Hb level
Time frame: 12 months
Length of hospital stay
Number of days spent in hospital
Time frame: 1 month
Pain score
Pain score will be assessed using visual analogue scale
Time frame: 5 years
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