An interventional study of Renal biopsy and Cryoablation in Renal Tumor, sponsored by I.M. Sechenov First Moscow State Medical University. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 142 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
•CT-confirmed renal mass > 4 to 7 cm (T1b)
Exclusion Criteria:
Patients with T1b renal tumor and ECOQ\>20
Procedure: Renal biopsy · Procedure: Cryoablation
Patients with T1b renal tumor
Procedure: Partial nephrectomy
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
Local 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
Plan to share: No
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I.M. Sechenov First Moscow State Medical University