Renal Tumor
Conditions
Keywords
Cryoablation, Renal cancer, Partial nephrectomy
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.
Interventions
PROCEDURERenal biopsy
Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
PROCEDURECryoablation
Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
PROCEDUREPartial nephrectomy
Partial nephrectomy will be performed on the basis of the center and according to the current protocols
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Length of hospital stay | 1 month | Number of days spent in hospital |
| Pain score | 5 years | Pain score will be assessed using visual analogue scale |
| Blood loss | 12 months | Pre- and postoperative Hb level |
Countries
Russia
Outcome results
None listed