Renal Hypothermia During Partial Nephrectomy
The Objective is to determine if renal hypothermia during open partial nephrectomy results in improved post-operative renal function compared to warm ischemia.
Primary Aim is to determine the effect of hypothermia on preservation of overall renal function compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.
Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal function.
Secondary Aim is to determine the effect of hypothermia on preservation of affected renal function (kidney with the tumor) compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.
Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal function.
Procedure: Renal hypothermia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy|
- Renal function [ Time Frame: 12 months ] [ Designated as safety issue: No ]Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.
- Difference in affected renal function [ Time Frame: 12 months ] [ Designated as safety issue: No ]Side-specific renal function will be calculated by the product of overall glomerular filtration (determined from 99mTc-DTPA plasma clearance) and relative renal contribution (determined from 99mTc-DTPA renal scintigraphy).
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
No Intervention: No hypothermia
After clamping of the renal vessels, no ice slush will be used.
saline ice slush around kidney for 10 minutes.
Procedure: Renal hypothermia
Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.
When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery.
Other Name: Ice
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 renal scintigraphy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529658
|Canada, Nova Scotia|
|Capital Disctrict Health Authority|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|London Health Science Centre|
|London, Ontario, Canada, N6C 2R5|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1y 4E9|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2N2|
|Centre hospitalier universitaire de Québec|
|Québec, Quebec, Canada, G1R 2J7|
|Principal Investigator:||Ilias Cagiannos, MD||The Ottawa Hospital, Ottawa Hospital Research Institute|