PRedictive Accuracy of Initial Stone Burden Evaluation.

NCT04746378 | Enrolling By Invitation

• 1 other identifier: BC-7295
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Ureterolithiasis; Nephrolithiasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Stone Free Status

  Any residual stone fragments after the initial treatment

  1 day to 3 months

Secondary Outcomes (2)

• Operative Time

  intra-operative

• Complication

  30 days

Study Arms (3)

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; Diagnostic Test: Computed Tomography, SA; Diagnostic Test: Computed Tomography, 3D

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; Diagnostic Test: Computed Tomography, SA; Diagnostic Test: Computed Tomography, 3D

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; Diagnostic Test: Computed Tomography, SA; Diagnostic Test: Computed Tomography, 3D

Interventions

Computed Tomography, CSD DIAGNOSTIC_TEST

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

Also known as: Cumulative Stone Diameter

extracorporeal shockwave lithotripsy; percutaneous nephrolithotomy; uretero(reno)scopy

Computed Tomography, SA DIAGNOSTIC_TEST

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

Also known as: Stone Surface Area

extracorporeal shockwave lithotripsy; percutaneous nephrolithotomy; uretero(reno)scopy

Computed Tomography, 3D DIAGNOSTIC_TEST

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

Also known as: Stone Volume

extracorporeal shockwave lithotripsy; percutaneous nephrolithotomy; uretero(reno)scopy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• EAU Young Academic Urologists Urolithiasis and Endourology Working Group: collaborator
• European Association of Urology Section of Uro-Technology: collaborator
• Endourological Society TOWER Research Team: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Eastern-Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Urolithiasis; Ureterolithiasis; Nephrolithiasis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Thomas Tailly, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 9, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

BE (1)