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

NCT05592457 | Unknown DMC FDA Device

• 1 other identifier: MDCT in ESWL
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Stone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• density of stone and other factors

  3weeks

Interventions

MSCT DIAGNOSTIC_TEST

multislice computed tomography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 11751, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 9048851 BACKGROUND

• 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.

  PMID: 11223679 BACKGROUND

• 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.

  PMID: 21722946 BACKGROUND

• 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.

  PMID: 18158009 BACKGROUND

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• gehan sayed, MD

  Assiut University

  STUDY DIRECTOR

• Doria mohamed, md

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Dina Essam, resident

CONTACT

01027664829; Dina.14224214@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: October 15, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

EG (1)