Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy
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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 |
- 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 |
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| Contact: Laura Legere, BScN | 416-946-2282 | laura.legere@uhn.ca |
| Canada, Ontario | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: Michael Jewett, M.D. | |
| 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 Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013