Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

NCT ID: NCT01720693

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Partial Nephrectomy; Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hypoperfusion

Hypoperfusion of the renal artery

Group Type: EXPERIMENTAL

Hypoperfusion of renal artery

Intervention Type: PROCEDURE

The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal

Interventions

Hypoperfusion of renal artery

The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Jewett, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Hypoperfusion

Identifier Type: -

Identifier Source: org_study_id