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Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

Primary Purpose

Partial Nephrectomy, Renal Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Hypoperfusion of renal artery
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Partial Nephrectomy focused on measuring partial nephrectomy, hypoperfusion, renal function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must be at least 18 years old scheduled for open partial nephrectomy

Exclusion Criteria:

  • No prior diagnosis of renal artery disease

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hypoperfusion

Arm Description

Hypoperfusion of the renal artery

Outcomes

Primary Outcome Measures

To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow
renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury

Secondary Outcome Measures

Full Information

First Posted
October 29, 2012
Last Updated
February 10, 2015
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01720693
Brief Title
Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
Official Title
A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Nephrectomy, Renal Cell Carcinoma
Keywords
partial nephrectomy, hypoperfusion, renal function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypoperfusion
Arm Type
Experimental
Arm Description
Hypoperfusion of the renal artery
Intervention Type
Procedure
Intervention Name(s)
Hypoperfusion of renal artery
Intervention Description
The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal
Primary Outcome Measure Information:
Title
To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow
Description
renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury
Time Frame
up to 2 weeks prior to surgery and up to 24 hrs post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be at least 18 years old scheduled for open partial nephrectomy Exclusion Criteria: No prior diagnosis of renal artery disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jewett, M.D.
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

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