Radiation Doses of Pediatric Patients During Ureteroscopy and Percutaneous Nephrolithotomy

Radiation Dose of Pediatric Patients During Ureteroscopy

Sponsors

Lead sponsor: University of Pittsburgh

Source University of Pittsburgh
Brief Summary

The purpose of this study is to quantify the radiation exposure from diagnostic testing and surgical treatment during routine endourologic procedures for symptomatic urolithiasis.

Detailed Description

Routine endourologic procedures will be performed at the Childrens Hospital of Pittsburgh by one of the investigators listed on this study. Fluoroscopic radiation exposure during these procedures is used to guide the surgical devices that are used to treat the stones. The investigators will be measuring the radiation effective skin dose by two methods. First, the investigators will place two "Microdot" thermal leak detectors (TLD) on the patient. These devices which are the size and thickness of a dime will be within plastic bags taped to the patients body within the central focus of the fluoroscopy image. At the completion of the procedure the TLD's will be transferred to the Radiation Safety Office in Oakland to be read and the dose recorded.

Second, a flat chamber that is integral with all fluoroscopy machines used at Children's Hospital will measure the dose-area product (DAP) for each case which will allow us to calculate the effective dose. This device is a component of the colimeter on the arm of the x-ray machine used for fluoroscopy. It measures the radiation that is returned to the x-ray machine and calculates the dose delivered to the patient by comparing the amount delivered to the patient to the amount returned to the machine. Its use is automatic when any x-rays are delivered and does not involve any manipulation of the patient or alteration of normal procedure.

No additional procedures or change in duration is necessary for this study

Overall Status Recruiting
Start Date September 2010
Completion Date September 2020
Primary Completion Date September 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Exposed to fluoroscopic radiation through study completion, an average of 1 year
Enrollment 500
Condition
Eligibility

Sampling method: Probability Sample

Criteria:

Inclusion Criteria:

- Eligible subjects will be male and female volunteers of 0-18 years of age with documented urolithiasis who is undergoing a urologic procedure that utilizes fluoroscopy radiation.

- The racial, gender and ethnic characteristics of the proposed subject population reflect the demographics of Pittsburgh and the surrounding area and/or the population of the University of Pittsburgh.

- We shall attempt to recruit subjects in respective proportion to these demographics.

Exclusion Criteria:

- None

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Rajeev Chaudhry, MD Principal Investigator University of Pittsburgh
Overall Contact

Last name: Jennifer Clayton, BS

Phone: 412-692-7949

Email: [email protected]

Location
facility status contact contact_backup
Children's Hospital of Pittsburgh of UPMC Recruiting Rajeev Chaudhry, MD 412-692-3043 [email protected]
Location Countries

United States

Verification Date

November 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Pittsburgh

Investigator full name: Rajeev Chaudhry

Investigator title: Assistant Professor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Patients with urolithiasis

Description: To record the effective radiation dose to the patient during endourologic procedures to treat urolithiasis

Patient Data No
Study Design Info

Observational model: Other

Time perspective: Prospective

Source: ClinicalTrials.gov