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PRedictive Accuracy of Initial Stone Burden Evaluation.

Comparison of Predictive Value of Different Stone Burden Measurements for Outcomes After Urinary Stone Treatment.

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04746378
Acronym
PRAISE
Enrollment
1000
Registered
2021-02-09
Start date
2021-09-09
Completion date
2028-12-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis, Ureterolithiasis, Urolithiasis

Keywords

ureteroscopy, extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, stone burden, non-contrast computed tomography

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.

Interventions

DIAGNOSTIC_TESTComputed Tomography, CSD

Measurement of the stone burden by cumulative stone diameter, the sum of linear longest diameters of all the stones to be treated within one patient as measured on the CT or by additional rendering software

DIAGNOSTIC_TESTComputed Tomography, SA

Measurement of the stone burden by surface area, the sum of surface areas of all the stones to be treated within one patient as measured on the CT or by additional rendering software

DIAGNOSTIC_TESTComputed Tomography, 3D

Measurement of the stone burden by volume of all the stones to be treated within one patient, as measured on the CT or by additional rendering software

Sponsors

EAU Young Academic Urologists Urolithiasis and Endourology Working Group
CollaboratorUNKNOWN
European Association of Urology Section of Uro-Technology
CollaboratorUNKNOWN
Endourological Society TOWER Research Team
CollaboratorUNKNOWN
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stone Free Status1 day to 3 monthsAny residual stone fragments after the initial treatment

Secondary

MeasureTime frameDescription
Operative Timeintra-operativeTime needed to treat the stone burden as measured during one treatment session
Complication30 daysAny complication thet can be attributed to the procedure that was performed

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026