Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Long-term Effects Secondary to Cancer Therapy in Adults | — | UNRESOLVED | — |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
| Urinary Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cold ischemia procedure | Procedure | — | UNRESOLVED |
| warm ischemia procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo warm ischemia followed by partial nephrectomy.
- interventionNames
- Procedure: warm ischemia procedure
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo cold ischemia followed by partial nephrectomy.
- interventionNames
- Procedure: cold ischemia procedure
Primary outcomes (2)
- measure
- Creatinine clearance at 1 year
- timeFrame
- at 1 year after nephrectomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of solitary renal cortical tumor * Tumor size ≤ 4 cm * Candidate for open partial nephrectomy * Expected ischemia time \< 45 minutes * Normal renal function, defined as glomerular filtration rate (GFR) \> 60 mL/min * No evidence of distant metastasis * No evidence of local invasion of adjacent structures, including the adrenal gland * No evidence of tumor extension into the renal venous system * No evidence of ureteral obstruction on MAG-3 renal scan * No family history of renal cancer PATIENT CHARACTERISTICS: * ECOG performance status 0 * Life expectancy \> 5 years * No prior malignancy, except for non-melanomatous skin cancer PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (0)
Data not yet available