Clinical trial NCT04746378: PRedictive Accuracy of Initial Stone Burden Evaluation.
Official title: Comparison of Predictive Value of Different Stone Burden Measurements for Outcomes After Urinary Stone Treatment.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Urolithiasis
Ureterolithiasis
Nephrolithiasis
Keywords: ureteroscopy
extracorporeal shockwave lithotripsy
percutaneous nephrolithotomy
stone burden
non-contrast computed tomography
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: EAU Young Academic Urologists Urolithiasis and Endourology Working Group
name: European Association of Urology Section of Uro-Technology
name: Endourological Society TOWER Research Team
First posted: 2021-02-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing any stone treatment that have a pre-operative CT that can be used for post-processing evaluation of the stone burden with specified software. Primary stone treatment only.

Brief summary: This study is intended to be a prospective registry of patients undergoing any kind of stone treatment that have a pre-operative CT available. This imaging will be used to measure the stone burden in three different ways: in a single dimension (cumulative stone diameter), in two dimensions (surface area) and in three dimensions (volume).The primary purpose is to identify what way of measuring stone burden is most predictive of outcomes after stone treatment such as stone free status, operative time and complications.

Detailed description: The current EAU and AUA guidelines still base the recommendations for stone treatment on cumulative stone diameter, a linear measurement of the stone burden. Multiple nomograms rather use the stone burden's surface area to predict post-operative outcomes. More recently, volume has been prposed as the most accurate measure of stone burden and the variable to be reported in stone treatment literature. Although inuitively a three dimensional evaluation is most likely the most accurate representation of the stone burden to be treated.

Several reports however have compared different ways of measuring stone burden and could not confidently identify volume as the most accurate predictor of surgical outcomes.

With this study, we aim to prospectively collect data on a large group of patients that have a pre-operative CT scan available. This imaging will be used to assess the stone burden in different ways, linear, two dimensional and three dimensional. Both procedural and post-operative data will be collected to identify which of the measurements is most accurate in predicting outcomes such as stone free status, operative time and complications such as bleeding. Patients can be included regardless of the procedure that is proposed to treat the stone. After inclusion and after having undergone the procedure, at least one post-operative assessment is necessary to be able to evaluate the pre-operative variables against post-operative outcomes.

Eligibility criteria: Inclusion Criteria:

* Availability of computed tomography imaging
* Undergoing any of the previously described procedures: extracorporeal shockwave lithotripsy, uretero(reno)scopy or percutaneous nephrolithotomy
* Able to read and understand the information regarding the study and able to provide informed consent

Exclusion Criteria:

* Under the stated age limit
* No pre-operative computed tomography imaging available

Primary outcomes:
measure: Stone Free Status
timeFrame: 1 day to 3 months
Secondary outcomes:
measure: Operative Time
timeFrame: intra-operative
measure: Complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Ghent
state: Eastern-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Thomas Tailly, MD
role: PRINCIPAL_INVESTIGATOR
References: