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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00743236

Enrollment

Registered

2008-08-28

Start date

2008-08-31

Completion date

2009-06-30

Last updated

2017-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Perioperative/Postoperative Complications, Urinary Complications

Keywords

perioperative/postoperative complications, urinary complications, long-term effects secondary to cancer therapy in adults, stage I renal cell cancer

Brief 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.

Interventions

PROCEDUREcold ischemia procedure

Cold ischemia followed by partial nephrectomy

PROCEDUREwarm ischemia procedure

Warm ischemia followed by partial nephrectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Creatinine clearance at 1 year	at 1 year after nephrectomy.
Estimated glomerular filtration rate (GFR)	at 1 year after nephrectomy.

Secondary

Measure	Time frame
Evidence of local or metastatic recurrence	at 1 year after nephrectomy.
Cancer-specific survival	at 1 year after nephrectomy.
Overall survival	at 1 year after nephrectomy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026