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NCT Number: NCT05218811

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

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.

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Key information

Conditions

Kidney Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urological Research Network

Miami Lakes, Florida, 33016, United States

Location status: Recruiting

Location contact

CIELO GUERRA, BS

CONTACT

[email protected]

305-515-9887

EUSEBIO J LUNA, MD

SUB_INVESTIGATOR

FERNANDO J BIANCO, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoablation Assisted Partial Nephrectomy

Device

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.

Primary outcomes

  1. Recurrence - Oncological Control

    Time frame: 10 Years

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

Secondary outcomes

  1. Local Re-Intervention

    Time frame: 10 Years

    Either subsequent ablation or surgical exploration or surgical kidney removal

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cielo Guerra

CONTACT

[email protected]

3058227227

Eusebio J Luna, MD

CONTACT

[email protected]

3058227227

Sponsors and collaborators

Lead sponsor

Urological Research Network, LLC

Other

Registry information

Official study title

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery

Acronym: RCAPN

Important dates

Study start
2020
Primary completion
2026
Study completion
2041
First posted
Feb 1, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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