Urinary StoneNCT05592457
Role of Non-contrast MDCT in the Assessment of Upper Urinary Tract Calculi Post ESWL to Predict Its Success Rate
An observational study of Urinary Stone, run by Assiut University at 1 site in Egypt.
Trial summary
Urinary stones are a common disease affecting one in 11 people . Their clinical presentation varies from being silent to severe loin pain owing to urinary obstruction. Currently, ESWL is the treatment of choice for most renal calculi ⩽30 mm, with success rates of 60-99%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Urinary Stone
- What is being tested?
- MSCT
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 30 Oct 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Adult, Older adult
Study population: * Firstly All studies were performed by using a CT device. * the mean Hounsfield unit was calculated. The skin-to-stone distance (SSD) was calculated by measuring three distances from the stone to the skin at 0, 45, and 90°; * after the first session of ESWL by one to three weeks Low dose NCCT(MA=175)will be done to determine the measurements of the fragments or the stone if not fragmented including their density and size will be taken, For the density, if decreased or not changed continuation versus stop will be evaluated, while for the size the fragmentation will be assessed as 1- complete fragmentation is the fragment size <4 mm, 2- partial fragmentation if size = 4-5 mm and 3- incomplete fragmentation if the size of fragment more than or equal 6 mm.
Who may be able to join
- patients older than 18 years.
- stone size up to 25 mm for renal pelvic stones and up to 15 mm for upper ureteric stones.
- SSD < 11 cm.
Who cannot join
- any patient with contraindications to ESWL as
- uncontrolled urinary infection.
- clotting alterations.
- aortic or renal artery aneurysm.
- pregnancy.
- serious skeletal malformations.
- serious obesity and or contraindications to CT as pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 11751
dina essam, resident, 01027664829, Dina.14224214@med.aun.edu.eg
About this study
Urinary stones are a common disease affecting one in 11 people . Their clinical presentation varies from being silent to severe loin pain owing to urinary obstruction. Currently, ESWL is the treatment of choice for most renal calculi ⩽30 mm, with success rates of 60-99%. Although many treatment options exist, ESWL has the advantages of simplicity and non-invasiveness. In contrast, failure of a first ESWL attempt requires a follow-up ESWL procedure, or an alternative procedure, both of which increase medical costs.
Advancements in imaging have significantly contributed to this process. In the mid- 1990s, computed tomography (CT) began to replace intravenous urography (IVU), abdominal films (KUB), and ultrasound (US) in stone diagnosis. Studies demonstrated that CT had superior sensitivity and specificity for stone diagnosis compared to the aforementioned modalities. Now non-contrast multidetector CT (NC-MDCT) is the gold standard for the detection of urinary system calculi. CT is also clinically useful as it can show alternate renal and non-renal pathology if present.
Many factors have been reported to predict ESWL outcome, such as skin-to-stone distance (SSD), stone size, stone location, multiplicity, the energy used, and Hounsfield Unit (HU) values measured by non-contrast computed tomography (NCCT).
Read the detailed description
Excellent fragmentation results are produced using ESWL. However, the retention of post-ESWL fragments in the kidney continues to be a significant medical issue. Only 32% of calcium stone patients in research were found to remain stone-free for 12 months following ESWL, according to the results. As a result, it appears that fragment growth and persistence are frequent after ESWL [10].
The first ESWL residual that is accessible must undergo a thorough stone analysis to properly carry out the subsequent treatments to prevent relapse or recurrent stone because stone-free rates after ESWL are directly connected to stone placement, size, number, and composition
- Conditions
- Urinary Stone
- Being tested
- MSCT
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCTDiagnostic test
multislice computed tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
ct follow up during swl
Correlation between the stone density before and during ESWL sessions to determine if this predicts the success prevent new ESWL.
Measured: 3 weeks
stone Hounsfield
Determine the role of the density of the residual stone fragments in the prediction of the complication during ESWL.
Measured: 3weeks
Secondary outcomes (1)
density of stone and other factors
Correlate between stone density and other factors in the prediction of the success of ESWL.
Measured: 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Oct 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary StoneStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Essam, Assiut University
- Investigators
- gehan sayed, MD, Study director, Assiut UniversityDoria mohamed, md, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592457
- Sponsor's protocol ID
- MDCT in ESWL
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wolf JS Jr, Clayman RV. Percutaneous nephrostolithotomy. What is its role in 1997? Urol Clin North Am. 1997 Feb;24(1):43-58. doi: 10.1016/s0094-0143(05)70353-0.
PubMed 9048851Rassweiler JJ, Renner C, Chaussy C, Thuroff S. Treatment of renal stones by extracorporeal shockwave lithotripsy: an update. Eur Urol. 2001 Feb;39(2):187-99. doi: 10.1159/000052435.
PubMed 11223679Johnson EK, Faerber GJ, Roberts WW, Wolf JS Jr, Park JM, Bloom DA, Wan J. Are stone protocol computed tomography scans mandatory for children with suspected urinary calculi? Urology. 2011 Sep;78(3):662-6. doi: 10.1016/j.urology.2011.02.062. Epub 2011 Jun 30.
PubMed 21722946Weld KJ, Montiglio C, Morris MS, Bush AC, Cespedes RD. Shock wave lithotripsy success for renal stones based on patient and stone computed tomography characteristics. Urology. 2007 Dec;70(6):1043-6; discussion 1046-7. doi: 10.1016/j.urology.2007.07.074.
PubMed 18158009
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Non-contrast MDCT in the Assessment of Upper Urinary Tract Calculi Post ESWL to Predict Its Success Rate
- ClinicalTrials.gov ID
- NCT05592457
- Acronym / sponsor ID
- MDCT in ESWL
- Conditions
- Urinary Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 24 Oct 2022 (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.
Urinary stones are a common disease affecting one in 11 people . Their clinical presentation varies from being silent to severe loin pain owing to urinary obstruction. Currently, ESWL is the treatment of choice for most renal calculi ⩽30 mm, with success rates of 60-99%. Although many treatment options exist, ESWL has the advantages of simplicity and non-invasiveness. In contrast, failure of a first ESWL attempt requires a follow-up ESWL procedure, or an alternative procedure, both of which increase medical costs.
Advancements in imaging have significantly contributed to this process. In the mid- 1990s, computed tomography (CT) began to replace intravenous urography (IVU), abdominal films (KUB), and ultrasound (US) in stone diagnosis. Studies demonstrated that CT had superior sensitivity and specificity for stone diagnosis compared to the aforementioned modalities. Now non-contrast multidetector CT (NC-MDCT) is the gold standard for the detection of urinary system calculi. CT is also clinically useful as it can show alternate renal and non-renal pathology if present.
Many factors have been reported to predict ESWL outcome, such as skin-to-stone distance (SSD), stone size, stone location, multiplicity, the energy used, and Hounsfield Unit (HU) values measured by non-contrast computed tomography (NCCT).
Detailed description
Excellent fragmentation results are produced using ESWL. However, the retention of post-ESWL fragments in the kidney continues to be a significant medical issue. Only 32% of calcium stone patients in research were found to remain stone-free for 12 months following ESWL, according to the results. As a result, it appears that fragment growth and persistence are frequent after ESWL [10].
The first ESWL residual that is accessible must undergo a thorough stone analysis to properly carry out the subsequent treatments to prevent relapse or recurrent stone because stone-free rates after ESWL are directly connected to stone placement, size, number, and composition
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Firstly All studies were performed by using a CT device. * the mean Hounsfield unit was calculated. The skin-to-stone distance (SSD) was calculated by measuring three distances from the stone to the skin at 0, 45, and 90°; * after the first session of ESWL by one to three weeks Low dose NCCT(MA=175)will be done to determine the measurements of the fragments or the stone if not fragmented including their density and size will be taken, For the density, if decreased or not changed continuation versus stop will be evaluated, while for the size the fragmentation will be assessed as 1- complete fragmentation is the fragment size <4 mm, 2- partial fragmentation if size = 4-5 mm and 3- incomplete fragmentation if the size of fragment more than or equal 6 mm.
Key inclusion criteria (3 listed)
- patients older than 18 years.
- stone size up to 25 mm for renal pelvic stones and up to 15 mm for upper ureteric stones.
- SSD < 11 cm.
Key exclusion criteria (7 listed)
- any patient with contraindications to ESWL as
- uncontrolled urinary infection.
- clotting alterations.
- aortic or renal artery aneurysm.
- pregnancy.
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 |
|---|---|---|
| MSCTmultislice computed tomography | Diagnostic test | – |
Primary outcome
ct follow up during swl
Time frame: 3 weeks
Correlation between the stone density before and during ESWL sessions to determine if this predicts the success prevent new ESWL.
stone Hounsfield
Time frame: 3weeks
Determine the role of the density of the residual stone fragments in the prediction of the complication during ESWL.
1 secondary outcome
density of stone and other factors
Time frame: 3weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 9048851Wolf JS Jr, Clayman RV. Percutaneous nephrostolithotomy. What is its role in 1997? Urol Clin North Am. 1997 Feb;24(1):43-58. doi: 10.1016/s0094-0143(05)70353-0.
- Background: PubMed 11223679Rassweiler JJ, Renner C, Chaussy C, Thuroff S. Treatment of renal stones by extracorporeal shockwave lithotripsy: an update. Eur Urol. 2001 Feb;39(2):187-99. doi: 10.1159/000052435.
- Background: PubMed 21722946Johnson EK, Faerber GJ, Roberts WW, Wolf JS Jr, Park JM, Bloom DA, Wan J. Are stone protocol computed tomography scans mandatory for children with suspected urinary calculi? Urology. 2011 Sep;78(3):662-6. doi: 10.1016/j.urology.2011.02.062. Epub 2011 Jun 30.
- Background: PubMed 18158009Weld KJ, Montiglio C, Morris MS, Bush AC, Cespedes RD. Shock wave lithotripsy success for renal stones based on patient and stone computed tomography characteristics. Urology. 2007 Dec;70(6):1043-6; discussion 1046-7. doi: 10.1016/j.urology.2007.07.074.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
gehan sayed, MD study director
Assiut University
Doria mohamed, md study director
Assiut University
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 Urinary Stone, run by Assiut University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Essam, resident (01027664829, Dina.14224214@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ct follow up during swl (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592457, which also lists 4 linked publications.
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 25 Oct 2022.