Trials / Completed
CompletedNCT00743236
Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer
A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Kidney Cancer
- Long-term Effects Secondary to Cancer Therapy in Adults
- Perioperative/Postoperative Complications
- Urinary Complications
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | cold ischemia procedure | Cold ischemia followed by partial nephrectomy |
| PROCEDURE | warm ischemia procedure | Warm ischemia followed by partial nephrectomy |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2008-08-28
- Last updated
- 2017-04-06
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00743236. Inclusion in this directory is not an endorsement.