Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 55 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Patients are scheduled for a surgical procedure: robotic partial nephrectomy, and the investigators will use a cryoablation probe(s) for selective ischemia rather than full blood flow interruption with a vascular clamp
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment group 		Patients underwent Cryotheapy assisted partial nephrectomy
  • Device: Cryoablation Assisted Partial Nephrectomy
    Cryoablation Assisted Partial Nephrectomy is monitored under Ultrasound guidance, A Cryoablation machine (FDA Approved Device) along with its Cryoprobes are used in the study The Cryoprobes are placed in close to the endophytic tumor margins. The tumor boundary area will undergo one freezing cycles. Tumor is excised after 5 minutes of freezing cycle. Thawing process is passive, renal defect repair is conducted during thawing process.

Recruiting Locations

Urological Research Network
Miami Lakes, Florida 33016
Contact:
CIELO GUERRA, BS
305-515-9887
CIELO@BESTUROLOGY.NET

More Details

Status
Recruiting
Sponsor
Urological Research Network, LLC

Study Contact

Eusebio J Luna, MD
3058227227
drluna@research.surgery

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.