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
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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 ]

Enrollment: 16
Study Start Date: January 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (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.
    Other Names:
    • 4.5cmCi 99mTechnetium labeled diethylene-triamine-penta acetate (DTPA)
    • Neoprobe 2000 gamma probe
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587548

Locations
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Manpreet Grewal, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Manpreet Grewal, M.D., Mayo Clinic Jacksonville
ClinicalTrials.gov Identifier: NCT00587548     History of Changes
Other Study ID Numbers: 79-06, MCJ092006
Study First Received: December 21, 2007
Last Updated: September 27, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014