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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00743236
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase N/A
Start date August 2008
Completion date June 2009

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