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RecruitingInterventional

Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery

NCT ID: NCT05218811Sponsor: Urological Research Network, LLCLast updated: 2023-01-26

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.

Arms & interventions

  • DeviceCryoablation 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

  • Recurrence - Oncological Control

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

    Time frame: 10 Years

Secondary

  • Local Re-Intervention

    Time frame: 10 Years

  • Development or Progression of Chronic Kidney Disease (CKD)

    Time frame: 10 Years

  • Incidence of Metastatic disease

    Time frame: 10 Years

  • Survival

    Time frame: 10 years

Eligibility criteria

Sex: AllAge: 55 Years to 65 YearsHealthy 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

Study locations (1)

Urological Research Network

Miami Lakes, Florida, 33016

Recruiting
CIELO GUERRA, BS · Contact
FERNANDO J BIANCO, MD · Principal Investigator
EUSEBIO J LUNA, MD · Sub Investigator

References

  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)