RecruitingNot ApplicableNCT05725421

Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy

Oncologic, Functional and Surgical Outcomes for Patients Undergoing Radical Nephrectomy for Low-Risk Renal Cell Carcinoma and Recipients of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy


Sponsor

Case Comprehensive Cancer Center

Enrollment

5 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to investigate a novel approach to offer more ESRD participants the benefits associated with renal transplantation by increasing the supply of available allografts


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new surgical approach for kidney transplants: removing a small tumor from a donor kidney before transplanting it into someone who needs a new kidney. This could expand the pool of available donor kidneys. **You may be eligible as a donor if...** - You are over 50 years old - You have a small kidney tumor (cT1a) that needs a partial removal anyway - You are motivated primarily by a desire to donate (altruistic) - Your kidney function is strong enough to donate **You may NOT be eligible as a donor if...** - Your tumor characteristics are not suitable for this approach - Your remaining kidney function after donation would be inadequate - You have other significant health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDonor Radical and Partial Nephrectomy

Donor participants will undergo laparoscopic radical nephrectomy (RN) . Donor kidney then will undergo cold perfusion and ex-vivo partial nephrectomy (PN) with cold ischemia. During PN, careful inspection of tumor will be performed to ensure it is well-encapsulated. If any infiltrative features (versus well encapsulated tumor) are noted intraoperatively then transplant will not be performed. Multiple surgical margins will be sent (either frozen section or standard with priority). If final margins are positive or concerning, then transplant will not be performed. Biopsies of the tumor will be performed and sent to pathology (either frozen section or standard with priority).

PROCEDUREKidney Transplantation

The donor kidney will remain on ice while pathologic analysis is performed, and transplant recipient surgery is initiated (if pathologic analysis satisfactory). Cold ischemia with delay for pathology will have minimal functional impact in this setting based on extensive prior experience with renal transplantation where kidneys are routinely kept hypothermic for several hours prior to transplantation.

PROCEDURELaparoscopic Radical Nephrectomy

Radical nephrectomy consists of the removal of the kidney together with the perirenal fat and regional lymph nodes. The transperitoneal approach allows early control of the renal vessels.


Locations(1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05725421


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