Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach (RCAPN)

Urological Research Network, LLC

Status: Enrolling

Conditions: Kidney Neoplasms

Treatments: Device: Cryoablation Assisted Partial Nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05218811

URN-202000244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Treatment group

Experimental group

Description:

Patients underwent Cryotheapy assisted partial nephrectomy

Treatment:

Device: Cryoablation Assisted Partial Nephrectomy