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

NCT ID: NCT05592457

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2024-10-30

Brief 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).

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

MSCT

multislice computed tomography

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Dina Essam

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

gehan sayed, MD

Role: STUDY_DIRECTOR

Assiut University

Doria mohamed, md

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina Essam, resident

Role: CONTACT

Dina.14224214@med.aun.edu.eg

01027664829

Facility Contacts

dina essam, resident

Role: primary

Dina.14224214@med.aun.edu.eg

01027664829

References

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.

Reference Type: BACKGROUND

PMID: 9048851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11223679 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21722946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18158009 (View on PubMed)

Other Identifiers

MDCT in ESWL

Identifier Type: -

Identifier Source: org_study_id