PRedictive Accuracy of Initial Stone Burden Evaluation.

Urolithiasis Clinical Trial

— PRAISE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04746378
• Other study ID #: BC-7295
• Status: Enrolling by invitation
• Start date: September 9, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis
• Urolithiasis

Intervention

Diagnostic Test:
• Computed 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
• Computed 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
• Computed 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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Gent	Eastern-Flanders

Sponsors (4)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone Free Status	Any residual stone fragments after the initial treatment	1 day to 3 months
Secondary	Operative Time	Time needed to treat the stone burden as measured during one treatment session	intra-operative
Secondary	Complication	Any complication thet can be attributed to the procedure that was performed	30 days