Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01720693
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Partial Nephrectomy; Renal Cell Carcinoma	Procedure: Hypoperfusion of renal artery	Phase 2

Study Design

• Study Type: Interventional
• 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: Jun 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01720693
• Other Study ID Numbers: Hypoperfusion
• First Posted: Nov 2, 2012
• Last Update Posted: Feb 11, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by University Health Network, Toronto: partial nephrectomy; hypoperfusion; renal function
• Additional relevant MeSH terms: Carcinoma, Renal Cell

Study Results

No Results Posted as of Feb 11, 2015