Warm Ischemia or Cold Ischemia During Surgery in Treating Patients With Stage I Kidney Cancer

Wake Forest University (WFU)

Status: Completed

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

Treatments: Procedure: warm ischemia procedure; Procedure: cold ischemia procedure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00743236

CCCWFU-89108

CDR0000612519 (Registry Identifier)

NCI-2009-01120 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients undergo warm ischemia followed by partial nephrectomy.

Treatment:

Procedure: warm ischemia procedure

Arm II

Experimental group

Description:

Patients undergo cold ischemia followed by partial nephrectomy.

Treatment:

Procedure: cold ischemia procedure