Impact of Low Dose Fluoroscopy in Ureteroscopy

Status Completed

Clinical Trial Summary

One of the most effective strategies to decrease radiation exposure during ureteroscopy is to use low dose. However, the quality of the image obtained is inferior to full dose image. The main concern is to maintain the stone free and complication rate despite the inferior quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead of full dose would impact in a reduction of total radiation exposure despite a possible increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18 years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled regarding their treatment options. Patients who failed spontaneous passage or medical treatment or chose endourologic treatment were included in this study. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study.

Clinical Trial Description

Several studies support an association between increasing cancer risk with increasing exposure to radiation. Typical radiation exposure for a patient submitted to ureteroscopy ranges from 2.5 to 100 mSv. The International Commission on Radiological Protection recommends an annual occupational radiation exposure limit of no more than 50 mSv per year. One of the most effective strategies to decrease radiation exposure during ureteroscopy is to use low dose. However, the quality of the image obtained is inferior to full dose image. The main concern is to maintain the stone free and complication rate despite the inferior quality of image obtained. Our aim was to evaluate if reducing the dose of fluoroscopy to ¼ instead of full dose would impact in a reduction of total radiation exposure despite a possible increase in fluoroscopy time. Also, if this strategy would impact in operation time, stone free rate and complication rate of unilateral semi-rigid ureteroscopy for ureteral stone treatment due too less than optimal fluoroscopy image. All patients over 18 years old diagnosed with ureteral stone from 5 mm to 20 mm in diameter by CT scan were counseled regarding their treatment options. Patients who failed spontaneous passage or medical treatment or chose endourologic treatment were included in this study. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02704949
Study type	Interventional
Source	University of Sao Paulo General Hospital
Contact
Status	Completed
Phase	N/A
Start date	August 2015
Completion date	May 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.