PRedictive Accuracy of Initial Stone Burden Evaluation. (PRAISE)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nephrolithiasis; Urolithiasis; Ureterolithiasis
• Intervention / Treatment: Diagnostic test: Computed Tomography, CSD; Diagnostic test: Computed Tomography, SA; Diagnostic test: Computed Tomography, 3D

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Belgium
  • Eastern-Flanders
    • Gent, Eastern-Flanders, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
extracorporeal shockwave lithotripsy; Patients that are included in the study and undergo a shockwave lithotripsy. The pre- and postoperative assessment remains the same across groups	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; Other Names: Cumulative Stone Diameter; Diagnostic test: 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; Other Names: Stone Surface Area; Diagnostic test: 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; Other Names: Stone Volume
uretero(reno)scopy; Patients that are included in the study and undergo a semirigid or flexible uretero(reno)scopy. The pre- and postoperative assessment remains the same across groups	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; Other Names: Cumulative Stone Diameter; Diagnostic test: 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; Other Names: Stone Surface Area; Diagnostic test: 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; Other Names: Stone Volume
percutaneous nephrolithotomy; Patients that are included in the study and undergo a percutaneous nephrolithotomy. The pre- and postoperative assessment remains the same across groups	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; Other Names: Cumulative Stone Diameter; Diagnostic test: 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; Other Names: Stone Surface Area; Diagnostic test: 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; Other Names: Stone Volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone Free Status	Any residual stone fragments after the initial treatment	1 day to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Time needed to treat the stone burden as measured during one treatment session	intra-operative
Complication	Any complication thet can be attributed to the procedure that was performed	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: EAU Young Academic Urologists Urolithiasis and Endourology Working Group; European Association of Urology Section of Uro-Technology; Endourological Society TOWER Research Team
• Investigators: Principal Investigator: Thomas Tailly, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: percutaneous nephrolithotomy; ureteroscopy; extracorporeal shockwave lithotripsy; non-contrast computed tomography; stone burden
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: BC-7295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently, we have not planned to share individual patient data with any other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No