Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

NCT01720693 | Terminated Phase 2

• 1 other identifier: Hypoperfusion
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

partial nephrectomy; hypoperfusion; renal function

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

hypoperfusion

EXPERIMENTAL

Hypoperfusion of the renal artery

Procedure: Hypoperfusion of renal artery

Interventions

Hypoperfusion of renal artery PROCEDURE

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

hypoperfusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No prior diagnosis of renal artery disease

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Michael Jewett, M.D.

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 2, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

CA (1)