Impact of Low Dose Fluoroscopy in Ureteroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Low Dose Fluoroscopy in Ureteroscopy

Conditions
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Ureteral Stone

Intervention / Treatment
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* Radiation: 1/4 fluoroscopy dose
* Radiation: Full-dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose<br>The intervention is to use 1/4 fluoroscopy dose while the ureteroscopy is being performed | Radiation: 1/4 fluoroscopy dose<br>* Use of 1/4 fluoroscopy dose while ureteroscopy is being performed<br>|
| Active Comparator: Full-dose<br>The intervention is to use full fluoroscopy dose while the ureteroscopy is being performed | Radiation: Full-dose<br>* Use of full fluoroscopy dose while ureteroscopy is being performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation exposure | Each group of patients (1/4 dose and full dose) will have assigned one dosimeter to assess the radiation exposure every procedure. The sum of radiation of each group will be compared at the completion of the study (2 years) , because individual radiation exposure is too low to be measured. Radiation exposure will be measured (data stored inside the dosimeter) by dosimeter in mSv units at each procedure and the total sum of radiation will be done at the end of the study (2 years). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | None residual fragment in the ureter identified by computed tomography 3 months after the procedure | 3 months | 
| complications | Clavien-Dindo surgical complication score | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urolithiasis, Fluoroscopy, Radiation, Ureteroscopy