Role of Non-contrast MDCT in the Assessment of Upper Urinary Tract Calculi Post ESWL to Predict Its Success Rate

Urinary Stone Clinical Trial

Official title:

Role of Non-contrast MDCT in the Assessment of Upper Urinary Tract Calculi Post ESWL to Predict Its Success Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592457
• Other study ID #: MDCT in ESWL
• Status: Recruiting
• Start date: October 15, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Dina Essam, resident
• Phone: 01027664829
• Email: Dina.14224214[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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%. 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

Diagnostic Test:
• MSCT
multislice computed tomography

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Johnson 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. — View Citation

Rassweiler JJ, Renner C, Chaussy C, Thüroff S. Treatment of renal stones by extracorporeal shockwave lithotripsy: an update. Eur Urol. 2001 Feb;39(2):187-99. Review. — View Citation

Weld 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. — View Citation

Wolf JS Jr, Clayman RV. Percutaneous nephrostolithotomy. What is its role in 1997? Urol Clin North Am. 1997 Feb;24(1):43-58. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks
Primary	stone Hounsfield	Determine the role of the density of the residual stone fragments in the prediction of the complication during ESWL.	3weeks
Secondary	density of stone and other factors	Correlate between stone density and other factors in the prediction of the success of ESWL.	3weeks