- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07506031
Shear Wave Elastografi for å forutsi resultater av ekstrakorporal sjokkbølgelitotripsi ved nyresteiner hos barn (SWE-ESWL)
Evaluering av Shear Wave Elastografi som en prediktor for resultater av ekstrakorporal sjokkbølgelitotripsi og steinsammensetning hos barn "En prospektiv studie"
This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound.
Pediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition.
This study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Banī Suwayf, Egypt, 62511
- faculty of medicine Beni Suef university hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Pediatric patients under 18 years of age diagnosed with renal stones measuring 6-20 mm and scheduled for extracorporeal shock wave lithotripsy (ESWL). Patients will be recruited from the outpatient clinic and followed for 3 months.
Proper history, examination and basic laboratory investigations (CBC, coagulation profile, kidney and Liver functions, urine analysis and urine culture and sensitivity) will be performed for all participants.
Low dose CTUT will be performed as usual for all patient to record stone location, size (maximum longitudinal and transverse dimensions), and HU.
Renal stone elastography values will be measured by a single radiologist using grayscale renal US and SWE.
SWE measurements will be performed once prior to ESWL. A Philips EPİQ7 system (Philips Medical Systems, Bothell, WA) with a 1-5-MHz abdominal probe will be used for the procedure.
Beskrivelse
Inclusion Criteria:
-
Inclusion criteria:
- Single Renal stones measured 6- 20 mm in maximal dimension.
- ESWL will be planned as the first line of treatment.
Exclusion Criteria:
- Patients with internal ureteral stent.
- ureteral stones.
- abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).
- active UTI at time of ESWL.
- coagulopathy .
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Pediatric Patients Undergoing ESWL
Pediatric patients (<18 years) with renal stones (6-20 mm) undergoing extracorporeal shock wave lithotripsy (ESWL). All patients will undergo baseline shear wave elastography (SWE) assessment prior to treatment. Patients will be followed for 3 months to evaluate ESWL success and its correlation with SWE measurements, Hounsfield units (HU), and stone composition. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ESWL Success Rate
Tidsramme: 3 months with maximum 3 sessions ESWL
|
Treatment success defined as absence of stone fragments or presence of clinically insignificant residual fragments ≤2 mm on imaging, without symptoms, obstruction, or urinary tract infection. |
3 months with maximum 3 sessions ESWL
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary Outcomes Related to SWE and ESWL
Tidsramme: Up to 3 months after ESWL
|
Assessment of secondary outcomes including:
|
Up to 3 months after ESWL
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- FMBSUREC/02122025/Badawy
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .