Kidney Cancer Clinical Trial
Official title:
A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
RATIONALE: Warm ischemia is the clamping of blood vessels without cooling the kidney. Cold
ischemia is the clamping of blood vessels with kidney cooling. It is not yet known whether
warm ischemia is more effective than cold ischemia in patients undergoing surgery for stage
I kidney cancer.
PURPOSE: This randomized phase III trial is studying warm ischemia to see how well it works
compared with cold ischemia during surgery in treating patients with stage I kidney cancer.
OBJECTIVES:
Primary
- 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
contralateral kidney.
Secondary
- 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.
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