UrolithiasisPRAISENCT04746378
PRedictive Accuracy of Initial Stone Burden Evaluation.
An observational study of Urolithiasis and Ureterolithiasis, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Ureterolithiasis, Nephrolithiasis
- What is being tested?
- Computed Tomography, CSD, Computed Tomography, SA and Computed Tomography, 3D
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Sep 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Under the stated age limit
- No pre-operative computed tomography imaging available
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urolithiasis, Ureterolithiasis, Nephrolithiasis
- Being tested
- Computed Tomography, CSD, Computed Tomography, SA, Computed Tomography, 3D
- Keywords
- ureteroscopy, extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, stone burden, non-contrast computed tomography
- Medical subject headings
- Urolithiasis, Ureterolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography, CSDDiagnostic test
Also called Cumulative Stone Diameter
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, SADiagnostic test
Also called Stone Surface Area
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, 3DDiagnostic test
Also called Stone Volume
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Computed Tomography, CSD; Diagnostic Test: Computed Tomography, SA; Diagnostic Test: Computed Tomography, 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone Free Status
Any residual stone fragments after the initial treatment
Measured: 1 day to 3 months
Secondary outcomes (2)
Operative Time
Time needed to treat the stone burden as measured during one treatment session
Measured: intra-operative
Complication
Any complication thet can be attributed to the procedure that was performed
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start9 Sep 2021
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- EAU Young Academic Urologists Urolithiasis and Endourology Working Group, European Association of Urology Section of Uro-Technology, Endourological Society TOWER Research Team
- Responsible party
- Sponsor
- Investigators
- Thomas Tailly, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746378
- Sponsor's protocol ID
- BC-7295
- Acronym
- PRAISE
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, we have not planned to share individual patient data with any other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Predictive Value of Different Stone Burden Measurements for Outcomes After Urinary Stone Treatment.
- ClinicalTrials.gov ID
- NCT04746378
- Acronym / sponsor ID
- PRAISE / BC-7295
- Conditions
- Urolithiasis, Ureterolithiasis, Nephrolithiasis
- Keywords
- ureteroscopy, extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, stone burden, non-contrast computed tomography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- EAU Young Academic Urologists Urolithiasis and Endourology Working Group, European Association of Urology Section of Uro-Technology, Endourological Society TOWER Research Team
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shockwave lithotripsy | – | Diagnostic Test: Computed Tomography, CSD, Diagnostic Test: Computed Tomography, SA, Diagnostic Test: Computed Tomography, 3DPatients that are included in the study and undergo a shockwave lithotripsy. The pre- and postoperative assessment remains the same across groups |
| uretero(reno)scopy | – | Diagnostic Test: Computed Tomography, CSD, Diagnostic Test: Computed Tomography, SA, Diagnostic Test: Computed Tomography, 3DPatients 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 |
| percutaneous nephrolithotomy | – | Diagnostic Test: Computed Tomography, CSD, Diagnostic Test: Computed Tomography, SA, Diagnostic Test: Computed Tomography, 3DPatients that are included in the study and undergo a percutaneous nephrolithotomy. The pre- and postoperative assessment remains the same across groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Under the stated age limit
- No pre-operative computed tomography imaging available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography, CSDAlso: Cumulative Stone DiameterMeasurement 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 test | extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, uretero(reno)scopy |
| Computed Tomography, SAAlso: Stone Surface AreaMeasurement 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 test | extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, uretero(reno)scopy |
| Computed Tomography, 3DAlso: Stone VolumeMeasurement 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 | Diagnostic test | extracorporeal shockwave lithotripsy, percutaneous nephrolithotomy, uretero(reno)scopy |
Primary outcome
Stone Free Status
Time frame: 1 day to 3 months
Any residual stone fragments after the initial treatment
2 secondary outcomes
Operative Time
Time frame: intra-operative
Complication
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided. Currently, we have not planned to share individual patient data with any other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Tailly, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Ureterolithiasis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone Free Status (time frame: 1 day to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.