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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences Identifier:
First received: August 27, 2008
Last updated: April 4, 2017
Last verified: April 2017

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.

Condition Intervention
Kidney Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Perioperative/Postoperative Complications
Urinary Complications
Procedure: cold ischemia procedure
Procedure: warm ischemia procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (masked role unspecified)
Primary Purpose: Treatment
Official Title: A Phase III Multi-Institutional Randomized Clinical Trial: Effect of Type of Ischemia - Warm vs Cold During Partial Nephrectomy - on Renal Function

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Creatinine clearance at 1 year [ Time Frame: at 1 year after nephrectomy. ]
  • Estimated glomerular filtration rate (GFR) [ Time Frame: at 1 year after nephrectomy. ]

Secondary Outcome Measures:
  • Evidence of local or metastatic recurrence [ Time Frame: at 1 year after nephrectomy. ]
  • Cancer-specific survival [ Time Frame: at 1 year after nephrectomy. ]
  • Overall survival [ Time Frame: at 1 year after nephrectomy. ]

Enrollment: 1
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo warm ischemia followed by partial nephrectomy.
Procedure: warm ischemia procedure
Warm ischemia followed by partial nephrectomy
Experimental: Arm II
Patients undergo cold ischemia followed by partial nephrectomy.
Procedure: cold ischemia procedure
Cold ischemia followed by partial nephrectomy

Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • ECOG performance status 0
  • Life expectancy > 5 years
  • No prior malignancy, except for non-melanomatous skin cancer


  • Not specified
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Please refer to this study by its identifier: NCT00743236

United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Joseph A. Pettus, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00743236     History of Changes
Other Study ID Numbers: CCCWFU-89108
CDR0000612519 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-01120 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Study First Received: August 27, 2008
Last Updated: April 4, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
perioperative/postoperative complications
urinary complications
long-term effects secondary to cancer therapy in adults
stage I renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Postoperative Complications
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on April 28, 2017