Comparing cryoablation and partial nephrectomy for treating T1b renal tumors
A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor
This study is testing whether cryoablation or partial nephrectomy works better for treating T1b kidney tumors and how each option affects patients' quality of life after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04506671 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term oncological and functional outcomes of cryoablation in patients with T1b renal tumors, specifically those with tumors measuring between 4 to 7 cm. It will compare these outcomes with those achieved through partial nephrectomy, focusing on the quality of life of patients post-treatment. The study will involve interventions such as renal biopsy, cryoablation, and partial nephrectomy to assess effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a CT-confirmed renal mass greater than 4 cm but less than 7 cm, classified as T1b.
Not a fit: Patients with multiple renal tumors, recurrence of renal tumors, or those with other oncological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a less invasive treatment option that preserves kidney function while effectively managing renal tumors.
How similar studies have performed: Other studies have shown promising results with cryoablation for renal tumors, indicating that this approach may be effective, although this specific comparison is less commonly explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Moscow
- Institute for Urology and Reproductive Health, Sechenov University. — Moscow, Russian Federation (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.