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A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy

18 Years
Open (Enrolling)
Renal Impairment, Kidney Diseases, Urologic Diseases, Cancer, Hypothermia, Kidney Cancer

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Trial Information

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
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.

Inclusion Criteria:

- Patients presenting with a renal mass deemed amenable to an open partial nephrectomy
regardless of stage, histology, presence of solitary kidney, multiple tumors or renal
function. Participating surgeons will identify patients they consider to be
appropriate candidates for partial nephrectomy with or without renal hypothermia.

- Willing to consent to randomization

- Willing to comply with study protocol

Exclusion Criteria:

- Bilateral renal tumours with planned surgery either partial or radical nephrectomy on
the contralateral kidney within the 12 months of the study.

- Life expectancy < 3 months as deemed by treating physician

- Age less than 18 years old

- Pregnancy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Renal function

Outcome Description:

Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Ilias Cagiannos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ottawa Hospital, Ottawa Hospital Research Institute


Canada: Ethics Review Committee

Study ID:

2010-767; CIHR MOP 269009



Start Date:

September 2012

Completion Date:

September 2016

Related Keywords:

  • Renal Impairment
  • Kidney Diseases
  • Urologic Diseases
  • Cancer
  • Hypothermia
  • Kidney Cancer
  • Renal function
  • Renal hypothermia
  • Nephrology
  • Nephrectomy
  • Renal tumor
  • Urology
  • Kidney
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Hypothermia
  • Kidney Diseases
  • Urologic Diseases
  • Renal Insufficiency



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