Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

Renal Cell Carcinoma Clinical Trial

Official title:

A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01720693
• Other study ID #: Hypoperfusion
• Status: Terminated
• Phase: Phase 2
• First received: October 29, 2012
• Last updated: February 10, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient must be at least 18 years old scheduled for open partial nephrectomy

Exclusion Criteria:

• No prior diagnosis of renal artery disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Partial Nephrectomy
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To perfect the Renal Hypoperfusion during partial nephrectomy is feasible safe and result in better renal function than complete occlusion of renal blood flow	renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury	up to 2 weeks prior to surgery and up to 24 hrs post surgery	Yes