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NCT05218811NARecruiting

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Urological Research Network, LLC

Start Date

5/15/2020

Completion Date

5/15/2041

Summary

Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.

Detailed Description

Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are \>2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia. The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.

Eligibility Criteria

Age Range: 55 years to 65 years

Inclusion Criteria: * Patients with ages between 45-90-year-old. * Renal tumor ≤ 7 cm in the greatest extension, \>50% exophitic. Exclusion Criteria: * Prior renal surgery * M1 Disease

Interventions

DEVICE

Cryoablation Assisted Partial Nephrectomy

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Conditions

Kidney Neoplasms

Locations

Urological Research Network

Miami Lakes, Florida 33016

United States