Full Text View
Tabular View
Contacts and Locations
No Study Results Posted
Related Studies
Intraoperative Gamma Probe Localization of the Ureter
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2006
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587548
  Purpose

This study is being done to find a different way to identify the ureters during an abdominal operation.

During some operations, the operating physician must identify where the ureters are to prevent injury to them. Typically, the surgeon calls the urologist to thread a small scope with a camera into the urethra (where the urine comes out) to place a wire into each of the two ureters to locate them. Instead of this procedure, we will inject a small amount of a radioactive chemical dye (TC99-DTPA)through a vein in your arm. The ureters can then be detected by a hand held probe called the 'gamma probe.' The TC99-DTPA dye passes through the body and is excreted through the urine. The goal of this study is that this probe will alert the physician when it placed directly over the ureters since the TC99-DTPA dye will highlight the ureters as the flow of urine goes through them.


Condition Intervention
Abdominal Surgery
Other: Localizing the ureters during surgery

MedlinePlus related topics: Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Intraoperative Gamma Probe Localization of the Ureter

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • If gamma probe localization of the ureters is possible, the need for ureteral stent placement could be obviated. [ Time Frame: Intraoperative procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: January 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Localizing the ureters during surgery
    One-time injection 4.5mCi of 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA) prior to the time of ureteral localization. The Neoprobe 2000 gamma probe will be utilized for ureter location.
Detailed Description:

The patient population includes those that are undergoing an elective, open, abdominal surgery.

The patient will receive, on average, 4.5mCi of Technetium labeled diethylene-triamine-penta acetate (DTPA) prior to the time of ureteral localization. The Neoprobe 2000 gamma probe will be placed on the field in sterile fashion in a manner similar to that which is performed during a minimally invasive parathyroidectomy or sentinel lymph node biopsy. The surgery will continue until the surgical team feels the time is appropriate for each ureter to be identified. At this point, the surgical team will use the gamma probe to localize the ureter and the attending physician will note either, "yes" or, "no" to their feeling is that they have correctly identified or did not identify each ureter. The surgical team will know that the ureter has been correctly identified when gentle manipulation of the tissue with forceps produces a "vermicular contraction" of the tubular structure suspected to be the ureter. No other tissue and/or structure produces this classic type of contraction. Background gamma counts, gamma counts over the ureter, and time between Tc-DTPA injection and ureteral localization will be recorded for each ureter sought. If the ureter cannot be localized with this technique, and the surgical team feels that it is imperative that the ureters be identified, then the attending surgeon may request a urologist to place stents in the standard, usual fashion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agrees to informed consent.
  • Patients undergoing elective, open, abdominal surgery
  • 18 years or older
  • Normal renal function defined by a serum creatinine less than 1.5mg/dL

Exclusion Criteria:

  • Pregnant or lactating females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587548

Contacts
Contact: Todd Berland, M.D. (904) 953-2000 ext 2523 berland.todd@mayo.edu

Locations
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Todd Berland, M.D.     904-953-2000 ext 2523     berland.todd@mayo.edu    
Contact: Philip P. Metzger, M.D.     (904) 953-2000 ext 2596     metzger.philip@mayo.edu    
Principal Investigator: Todd Berland, M.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Todd Berland, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic Jacksonville ( Todd Berland, M.D. )
Study ID Numbers: 79-06, MCJ092006
Study First Received: December 21, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00587548  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Mayo Clinic:
locate the ureters during abdominal surgery

Study placed in the following topic categories:
Nitric Oxide
Diethylenetriamine

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions
Nitric Oxide Donors

ClinicalTrials.gov processed this record on February 12, 2009