Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Kidney Neoplasms Clinical Trial

— RCAPN  

Official title:

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218811
• Other study ID #: URN-202000244
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: May 15, 2041

Study information

• Verified date: January 2023
• Source: Urological Research Network, LLC
• Contact: Eusebio J Luna, MD
• Phone: 3058227227
• Email: drluna[@]research.surgery
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 15, 2041
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Urological Research Network	Miami Lakes	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Urological Research Network, LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

Berger A, Kamoi K, Gill IS, Aron M. Cryoablation for renal tumors: current status. Curr Opin Urol. 2009 Mar;19(2):138-42. doi: 10.1097/MOU.0b013e328323f618. — View Citation

Ismail M, Nielsen TK, Lagerveld B, Garnon J, Breen D, King A, van Strijen M, Keeley FX Jr. Renal cryoablation: Multidisciplinary, collaborative and perspective approach. Cryobiology. 2018 Aug;83:90-94. doi: 10.1016/j.cryobiol.2018.06.002. Epub 2018 Jun 8. — View Citation

Makki A, Aastrup MB, Vinter H, Ginnerup B, Graumann O, Borre M, Nielsen TK. Renal cryoablation - does deep endophytic ablation affect the renal collecting system? Scand J Urol. 2020 Feb;54(1):33-39. doi: 10.1080/21681805.2019.1702094. Epub 2019 Dec 16. — View Citation

Ushijima Y, Asayama Y, Nishie A, Takayama Y, Kubo Y, Ishimatsu K, Ishigami K. Cryoablation for Secondary Renal Cell Carcinoma After Surgical Nephrectomy. Cardiovasc Intervent Radiol. 2021 Mar;44(3):414-420. doi: 10.1007/s00270-020-02709-w. Epub 2020 Nov 17. — View Citation

Zargar H, Atwell TD, Cadeddu JA, de la Rosette JJ, Janetschek G, Kaouk JH, Matin SF, Polascik TJ, Zargar-Shoshtari K, Thompson RH. Cryoablation for Small Renal Masses: Selection Criteria, Complications, and Functional and Oncologic Results. Eur Urol. 2016 Jan;69(1):116-28. doi: 10.1016/j.eururo.2015.03.027. Epub 2015 Mar 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence - Oncological Control	Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis	10 Years
Secondary	Local Re-Intervention	Either subsequent ablation or surgical exploration or surgical kidney removal	10 Years
Secondary	Development or Progression of Chronic Kidney Disease (CKD)	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
Secondary	Incidence of Metastatic disease	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
Secondary	Survival	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