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

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).

Study Overview

• Status: Recruiting
• Conditions: Urinary Stone
• Intervention / Treatment: Diagnostic test: MSCT

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 Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

• Study Contact: Name: dina essam, resident; Phone Number: 01027664829; Email: Dina.14224214@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 11751
    • Recruiting
    • Assiut University Hospital
    • Contact: dina essam, resident; Phone Number: 01027664829; Email: Dina.14224214@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
stone Hounsfield	Determine the role of the density of the residual stone fragments in the prediction of the complication during ESWL.	3weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
density of stone and other factors	Correlate between stone density and other factors in the prediction of the success of ESWL.	3weeks

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: gehan sayed, MD, Assiut University; Study Director: Doria mohamed, md, Assiut University

Publications and helpful links

General 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.
• Rassweiler 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.
• 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.
• 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. doi: 10.1016/j.urology.2007.07.074.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Urolithiasis; Calculi
• Other Study ID Numbers: MDCT in ESWL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No