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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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).
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.
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
Time frame: Within 30 days of surgery
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
Time frame: Within 30 days of surgery
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
Time frame: Within 180 days of surgery
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
Time frame: 1 year after surgery
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
Time frame: Up to 1 year after surgery
Surgical Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
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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.
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
Time frame: Within 180 days of surgery
Functional Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
Renal function as determined by: i. Delayed-graft function ii. Nadir post-transplant GFR iii. GFR measured at one year follow up
Time frame: 1 year after surgery
Oncologic Outcomes for a Renal Transplant Recipient After Ex-vivo Partial Nephrectomy
c. Oncologic outcomes as determined by local or distant recurrence of malignancy within one year of follow up, diagnosed by one year follow up CT imaging or other method used to determine presence of recurrent malignancy
Time frame: Up to 1 year after surgery
Participant Attitudes/Decision Making Surrounding Altruistic Kidney Donation
Participant attitudes and decision making surrounding altruistic donation as a component of surgery for a renal mass will be determined by a survey provided to participants at a preoperative visit prior to surgery and at the 12 month follow-up visit.
Time frame: 1 year after surgery
Participant Attitudes/Decision Making Surrounding Transplant Recipients
Participant attitudes and decision-making surrounding receipt of a kidney that previously had a small renal mass will be determined by a survey provided to participants at a preoperative visit prior to surgery and at the 12-month follow-up visit.
Time frame: 1 year after surgery