Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach (RCAPN)

January 24, 2023 updated by: Urological Research Network, LLC

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Urological Research Network
        • Principal Investigator:
          • FERNANDO J BIANCO, MD
        • Sub-Investigator:
          • EUSEBIO J LUNA, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence - Oncological Control
Time Frame: 10 Years
Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis
10 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Re-Intervention
Time Frame: 10 Years
Either subsequent ablation or surgical exploration or surgical kidney removal
10 Years
Development or Progression of Chronic Kidney Disease (CKD)
Time Frame: 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
10 Years
Incidence of Metastatic disease
Time Frame: 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
10 Years
Survival
Time Frame: 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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urological Research Network, LLC

Investigators

  • Principal Investigator: FERNANDO J BIANCO, MD, Urological Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Anticipated)

May 15, 2026

Study Completion (Anticipated)

May 15, 2041

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URN-202000244

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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