Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Not Applicable

Recruiting

• Conditions: Kidney Neoplasms
• Interventions: Device: Cryoablation Assisted Partial Nephrectomy

• Registration Number: NCT05218811
• Lead Sponsor: Urological Research Network, LLC

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.

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 Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2021-09-26
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Primary Completion: 2026-05-15
• Study Completion: 2041-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Cryoablation Assisted Partial Nephrectomy	Patients underwent Cryotheapy assisted partial nephrectomy

Primary Outcome Measures

Name	Time	Method
Recurrence - Oncological Control	10 Years	Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis

Secondary Outcome Measures

Name	Time	Method
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
Local Re-Intervention	10 Years	Either subsequent ablation or surgical exploration or surgical kidney removal
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
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

Trial Locations

Locations (1)

Urological Research Network; 🇺🇸 Miami Lakes, Florida, United States