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
Adults > 50 years
Willing and able to understand and sign informed consent
Must have high-quality pre-operative cross-sectional imaging (CT or MRI) to determine tumor characteristics and perform parenchymal volume analysis for split renal function
Patient who is a candidate for partial nephrectomy for cT1a mass who understands that partial nephrectomy is standard of care for such mass but wishes to be an altruistic kidney donor (primary incentive is altruism) via radical nephrectomy with loss of the entire kidney.
Known familial RCC syndrome
Preoperative GFR < 80 ml/min/1.73 m2
Proteinuria on urine dipstick or urinalysis (≥1+ considered positive)
Predicted new baseline GFR (NBGFR) following radical nephrectomy would be < 45
Single group
Donor Radical and Partial Nephrectomy
Procedure/SurgeryDonor 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).
Kidney Transplantation
Procedure/SurgeryThe 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.
Laparoscopic Radical Nephrectomy
Procedure/SurgeryRadical 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.
Safety and Feasibility of Radical Nephrectomy for a Small Renal Mass
Safety and feasibility as determined by peri-operative adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 30 days of surgery: i. Anemia ii. Acute kidney injury
Safety and feasibility for Renal Transplant Participants Receiving a Reconstructed Donor Kidney
Safety and feasibility as determined by peri-operative adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 30 days of surgery: i. Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula
Surgical Outcomes for a Radical Nephrectomy for a Small Renal Mass
a. Intermediate term surgical outcomes as determined by adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 180 days of surgery: i. Anemia ii. Acute kidney injury iii. Wound infection iv. Infection and infestations - Urinary tract infection, abscess
Functional Outcomes for a Radical Nephrectomy for a Small Renal Mass
Renal function as determined by: i. Post-operative baseline GFR \>45 ml/min/1.73m2 at time of follow up ii. GFR \>45 ml/min/1.73m2 at one year after radical nephrectomy
Oncologic Outcomes for a Radical Nephrectomy for a Small Renal Mass
c. Oncologic outcomes as determined by local or distant recurrence of malignancy within one year of follow up
Surgical Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Intermediate term surgical outcomes as determined by adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 180 days of surgery: i. Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula v. Wound infection vi. Infection and infestations - Other, Urinary tract infection, abscess, bacteremia
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