RCAPN: Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Sponsor
Urological Research Network, LLC (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218811
Collaborator
(none)
150
1
1
252
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryoablation Assisted Partial Nephrectomy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
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 clampPatients 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery
Actual Study Start Date :
May 15, 2020
Anticipated Primary Completion Date :
May 15, 2026
Anticipated Study Completion Date :
May 15, 2041

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Recurrence - Oncological Control [10 Years]

    Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis

Secondary Outcome Measures

  1. Local Re-Intervention [10 Years]

    Either subsequent ablation or surgical exploration or surgical kidney removal

  2. Development or Progression of Chronic Kidney Disease (CKD) [10 Years]

    De-Novo emergence of CDK or changes in CKD overtime based on variation from baseline. The international classification for CKD defined by serum estimated Glomerular Filtration Rates (GFR) will be used as measurement instrument using the following definitions: GFR categories in CKD G1 ≥90 Normal or high G2 60-89 Mildly decreased* G3a 45-59 Mildly to moderately decreased G3b 30-44 Moderately to severely decreased

  3. Incidence of Metastatic disease [10 Years]

    patients will be evaluated using imaging studies at fixed intervals as follows: at 6 months Renal Ultrasound at 1 year CT Urogram at 18 Months, 24 months and yearly thereafter with Renal Ultrasound CT Urograms will be performed as needed for cause

  4. Survival [10 years]

    If a patient expiries during the study interval we would procure the death certificate and do our best to determine cause of death

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 65 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urological Research Network Miami Lakes Florida United States 33016

Sponsors and Collaborators

  • Urological Research Network, LLC

Investigators

  • Principal Investigator: Fernando J Bianco, MD, Urological research Network

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Urological Research Network, LLC
ClinicalTrials.gov Identifier:
NCT05218811
Other Study ID Numbers:
  • URN-202000244
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022