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Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01720693
First received: October 29, 2012
Last updated: November 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Partial Nephrectomy
Renal Cell Carcinoma
Procedure: Hypoperfusion of renal artery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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 [ Time Frame: up to 2 weeks prior to surgery and up to 24 hrs post surgery ] [ Designated as safety issue: Yes ]
    renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hypoperfusion
Hypoperfusion of the renal artery
Procedure: Hypoperfusion of renal artery
The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720693

Contacts
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Michael Jewett, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Michael Jewett, M.D. University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01720693     History of Changes
Other Study ID Numbers: Hypoperfusion
Study First Received: October 29, 2012
Last Updated: November 1, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
partial nephrectomy
hypoperfusion
renal function

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Ischemia
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014