Impact of Low Dose Fluoroscopy in Ureteroscopy

NCT02704949 | Completed DMC

• 1 other identifier: 13788
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Stone

Keywords

Urolithiasis; Fluoroscopy; Radiation; Ureteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• stone free rate

  3 months

• complications

  3 months

Study Arms (2)

Low-dose

EXPERIMENTAL

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

Radiation: 1/4 fluoroscopy dose

Full-dose

ACTIVE COMPARATOR

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

Radiation: Full-dose

Interventions

1/4 fluoroscopy dose RADIATION

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

Low-dose

Full-dose RADIATION

Use of full fluoroscopy dose while ureteroscopy is being performed

Full-dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, Brazil

Location

MeSH Terms

Conditions

Ureterolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexandre Danilovic, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 10, 2016
• Study Start: August 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 29, 2021

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)