A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
- Determine the effect of warm ischemia during partial nephrectomy on long-term renal
function in patients with solitary stage I renal cortical tumor and normal
- Determine to what degree the contralateral kidney compensates for the damage inflicted
on the operated kidney during surgery.
- Determine the 1-year disease-specific and overall survival of these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo warm ischemia followed by partial nephrectomy.
- Arm II: Patients undergo cold ischemia followed by partial nephrectomy. Blood and urine
samples are collected periodically after nephrectomy to assess renal function.
Patients are followed at 1, 3, 6, 9 , and 12 months after nephrectomy.
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Treatment
Creatinine clearance at 1 year
Joseph A. Pettus, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|George Washington University Medical Center||Washington, District of Columbia 20037|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|
|Huntsman Cancer Institute at University of Utah||Salt Lake City, Utah 84112|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|