Intraoperative Gamma Probe Localization of the Ureter

Abdominal Surgery Clinical Trial

Official title:

Intraoperative Gamma Probe Localization of the Ureter

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00587548
• Other study ID #: 79-06
• Secondary ID: MCJ092006
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: September 27, 2010
• Start date: January 2006
• Est. completion date: January 2010

Study information

• Verified date: September 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	If gamma probe localization of the ureters is possible, the need for ureteral stent placement could be obviated.		Intraoperative procedure	Yes