Impact of Low Dose Fluoroscopy in Ureteroscopy

University of Sao Paulo General Hospital

Status: Completed

Conditions: Ureteral Stone

Treatments: Radiation: 1/4 fluoroscopy dose; Radiation: Full-dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02704949

13788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ureteral stone from 5 mm to 20 mm in diameter by CT scan

Exclusion criteria

• abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups

Low-dose

Experimental group

Description:

The intervention is to use 1/4 fluoroscopy dose while the ureteroscopy is being performed

Treatment:

Radiation: 1/4 fluoroscopy dose

Full-dose

Active Comparator group

Description:

The intervention is to use full fluoroscopy dose while the ureteroscopy is being performed

Treatment:

Radiation: Full-dose