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Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

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ClinicalTrials.gov Identifier: NCT01720693
Recruitment Status : Terminated (Low accrual)
First Posted : November 2, 2012
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Partial Nephrectomy Renal Cell Carcinoma Procedure: Hypoperfusion of renal artery Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
Study Start Date : June 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720693


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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01720693     History of Changes
Other Study ID Numbers: Hypoperfusion
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

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

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