Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryoablation Assisted Partial Nephrectomy.
- Who it may be relevant to
- Registry conditions: Kidney Neoplasms. Basic parameters: 55 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery
Overview
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.
Interventions
- 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.
Primary outcome measures
- Recurrence - Oncological Control [Time frame: 10 Years]
Secondary outcome measures (4)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Urological Research Network — Miami Lakes
Publications
- 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. PMID 29890126
- 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. PMID 31842655
- 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. PMID 19188767
- 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. PMID 33205290
- 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. PMID 25819723
Identifiers
NCT: NCT05218811 · URN-202000244