Nephrectomy Clinical Trials

Clinical trials related to Nephrectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

∙ For Donors:

• 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.

• Functional considerations:

• o Normal baseline renal function, with eGFR \> 80 ml/min/1.73 m2

⁃ No proteinuria on urine dipstick (negative/trace considered negative)

⁃ Predicted new baseline GFR (NBGFR) following radical nephrectomy would be ≥ 45

⁃ NBGFR would be calculated using previously described equation based on split renal function (SFR) and renal functional compensation (RFC)

⁃ NBGFR = global GFR x (SRFcontralateral from PVA) x 1.25 (average amount of RFC)2

• Tumor characteristics on pre-operative cross-sectional imaging:

‣ Tumor appears well-encapsulated

⁃ Tumor appears amenable to ex-vivo partial nephrectomy with reconstruction that will leave ≥75% of the functioning parenchyma intact and well vascularized

⁃ Low risk of complications for the recipient after ex-vivo PN based on surgeon judgment

⁃ Tumor is cT1a which is defined as ≤ 4cm and confined

⁃ Reconstructed kidney is likely to provide NBGFR for the recipient of \>30 ml/min/1.73 m2. This can be estimated as (global GFR)(SRFipsilateral) x 0.75(estimate that at least 75% of the function will be saved during ex vivo tumor excision and reconstruction). Of note most such kidneys will experience some positive functional compensation but this might be mitigated by a small amount of functional loss related to ischemia. Most studies suggest that this will really be an underestimate of the final GFR in the recipient.

∙ For Recipients:

• Age \>60

• Able to understand and willing to sign informed consent

• Presence of ESRD or CKD5 with likely progression to ESRD

• Does not have potential living donor

• Not likely to receive a more ideal donor kidney due to significant comorbidities and/or age

Locations
United States
Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Mohamed Eltemamy, MD
Eltemam@ccf.org
216-296-3693
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2026-06
Participants
Target number of participants: 5
Treatments
Experimental: cT1a Radical Nephrectomy + Donor Kidney Transplantation
Radical nephrectomy will be used to remove a cT1a renal mass in an altruistic kidney donor. The kidney obtained from the radical nephrectomy participant with the cT1a mass removed will be transplanted to the recipient using an allograft.
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov