Renal Hypothermia During Partial Nephrectomy

Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01529658
• Other study ID #: 2010-767; CIHR MOP 269009
• Status: Active, not recruiting
• Phase: N/A
• First received: February 6, 2012
• Last updated: October 25, 2016
• Start date: September 2012
• Est. completion date: September 2017

Study information

• Verified date: October 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Renal Cell
• Hypothermia
• Kidney Cancer
• Kidney Diseases
• Kidney Neoplasms
• Renal Impairment
• Renal Insufficiency
• Urologic Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Capital Disctrict Health Authority	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	London Health Science Centre	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Centre hospitalier universitaire de Québec	Québec	Quebec
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.	12 months	No
Secondary	Difference in affected renal function	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).	12 months	No