Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Mayo Clinic |
---|---|
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587548 |
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 |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Intraoperative Gamma Probe Localization of the Ureter |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Todd Berland, M.D. | (904) 953-2000 ext 2523 | berland.todd@mayo.edu |
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. |
Principal Investigator: | Todd Berland, M.D. | Mayo Clinic |
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 |
locate the ureters during abdominal surgery |
Nitric Oxide Diethylenetriamine |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Agents Pharmacologic Actions Nitric Oxide Donors |