A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Local recurrence
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Cryoablation group
Patients with T1b renal tumor and ECOQ>20
Intervention: Renal biopsy (Procedure)
Cryoablation group
Patients with T1b renal tumor and ECOQ>20
Intervention: Cryoablation (Procedure)
Partial nephrectomy group
Patients with T1b renal tumor
Intervention: Partial nephrectomy (Procedure)
Outcomes
Primary Outcomes
Local recurrence
Time Frame: 5 years
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Secondary Outcomes
- Pain score(5 years)
- Renal function(5 years)
- Metastatic progression(5 years)
- Blood loss(12 months)
- Length of hospital stay(1 month)
- Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)(5 years)
- Rate of adverse events(3 months)
Investigators
Dmitry Enikeev, MD, PhD
Deputy Director for Research
I.M. Sechenov First Moscow State Medical University