A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy
The incidence of renal cell carcinoma is increasing and in 2008 it is estimated that over
51,000 new renal cancers will be diagnosed in the United States. To preserve renal function,
urologists commonly remove the diseased segment of the kidney (partial nephrectomy) instead
of removing the entire kidney (radical nephrectomy). While the benefit of preserving
function in patients with renal cell carcinoma has become clear, optimal preservation
techniques are yet to be determined. Specifically, the role of hypothermia during partial
nephrectomy has been inadequately studied despite theoretical benefit. The investigators
objective is to assess the effectiveness of renal hypothermia during partial nephrectomy.
The investigators hypothesis is that renal hypothermia during partial nephrectomy results in
improved post-operative renal function compared to warm ischemia.
Methods: To test the investigators hypothesis, 180 partial nephrectomy patients will be
randomized to cold or warm ischemia. Global and side-specific renal function will be
assessed pre-operatively and 12 months post-operatively using radionucleotide clearance and
Significance: To the investigators knowledge, this study will be the first prospective trial
to evaluate the clinical impact of renal hypothermia during partial nephrectomy. Since renal
function preservation is the primary purpose of partial nephrectomy, these findings will
have an important impact on surgical technique and patient outcome.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
Ilias Cagiannos, MD
The Ottawa Hospital, Ottawa Hospital Research Institute
Canada: Ethics Review Committee
2010-767; CIHR MOP 269009
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