Ignite Creation Date:
2025-12-18 @ 4:09 AM
Ignite Modification Date:
2025-12-18 @ 4:09 AM
Study NCT ID:
NCT00743236
Status:
None
Last Update Posted:
2017-04-06 00:00:00
First Post:
2008-08-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
Status:
None
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: