Intraoperative Gamma Probe Localization of the Ureter

This study has been terminated.
(Decided not pursue the study)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587548
First received: December 21, 2007
Last updated: September 27, 2010
Last verified: September 2010

December 21, 2007
September 27, 2010
January 2006
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00587548 on ClinicalTrials.gov Archive Site
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Intraoperative Gamma Probe Localization of the Ureter
Intraoperative Gamma Probe Localization of the Ureter

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.

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.

Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Abdominal Surgery
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.
Other Names:
  • 4.5cmCi 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA)
  • Neoprobe 2000 gamma probe
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587548
79-06, MCJ092006
Yes
Manpreet Grewal, M.D., Mayo Clinic Jacksonville
Mayo Clinic
Not Provided
Principal Investigator: Manpreet Grewal, M.D. Mayo Clinic
Mayo Clinic
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP