Impact of Low Dose Fluoroscopy in Ureteroscopy

NCT ID: NCT02704949

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-05-31

Brief 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.

Detailed 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.

Conditions

Ureteral Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low-dose

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

Group Type: EXPERIMENTAL

1/4 fluoroscopy dose

Intervention Type: RADIATION

Use of 1/4 fluoroscopy dose while ureteroscopy is being performed

Full-dose

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

Group Type: ACTIVE_COMPARATOR

Full-dose

Intervention Type: RADIATION

Use of full fluoroscopy dose while ureteroscopy is being performed

Interventions

1/4 fluoroscopy dose

Use of 1/4 fluoroscopy dose while ureteroscopy is being performed

Intervention Type: RADIATION

Full-dose

Use of full fluoroscopy dose while ureteroscopy is being performed

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Danilovic, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

University of Sao Paulo General Hospital

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

13788

Identifier Type: -

Identifier Source: org_study_id