Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, 1151, Egypt
NCT Number: NCT07337954
This prospective single-center study compares 3D-CT volumetry versus traditional ellipsoid formula to determine critical stone burden predicting JJ stent necessity before ESWL for 1-2 cm renal stones. Fifty-six patients with single radio-opaque renal stones will receive up to two ESWL sessions using Dornier lithotripter without initial stenting. Stone characteristics will be assessed via NCCT: linear dimensions (ellipsoid formula), 3D volume (voxel-based segmentation), Hounsfield units, and skin-to-stone distance. Patients will be stratified by ESWL outcomes to compare volume measurements between clearance success and stent-requiring groups..
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 1151, Egypt
This prospective single-center study at Ain Shams University evaluates 3D-CT volumetry versus traditional ellipsoid formula for predicting critical stone burden requiring preoperative JJ stent placement in patients undergoing ESWL for 1-2 cm renal stones. Eligible patients (target n=56) with single radio-opaque renal stones will receive two ESWL sessions using Dornier lithotripter without initial stenting. Stone characteristics will be assessed via non-contrast CT (NCCT): linear dimensions (ellipsoid formula: length×width×height×0.52), 3D volume (automated voxel-based segmentation), Hounsfield units, and skin-to-stone distance.
Patients will be stratified by ESWL outcomes: stone clearance without stenting versus those requiring JJ stent due to complications (infection, incomplete fragmentation, obstruction/Stein Strasse). Volume measurements will be compared between groups using appropriate statistical tests (t-test, ROC analysis). The study aims to establish a 3D-CT volume threshold for stent prediction and validate its superiority over ellipsoid formula, particularly for irregular stone morphology.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ESWL delivered at 70-80 shocks/min, max 2500 shocks/session, voltage ramped to 90 kV. Stone localization via fluoroscopy.
Time frame: Pre-ESWL baseline
Comparison of stone volume measured by 3D-CT volumetry (voxel-based segmentation, cm³) versus traditional ellipsoid formula (greatest dimensions method) to determine critical stone burden predicting JJ stent necessity after ESWL. ROC analysis identified optimal cutoff (>1.88 cm³) for stent requirement
Time frame: 2 weeks post-ESWL
Rate of JJ stent placement due to ESWL complications (incomplete fragmentation, obstruction, Stein Strasse, infection)
Time frame: 2 weeks after maximum 2 ESWL sessions
Stone-free rate (complete clearance or asymptomatic fragments <4mm on KUB/ultrasound)
Ain Shams University
Other
Estimation of Critical Stone Burden Requiring JJ Stent Before Extracorporeal Shockwave Lithotripsy Using 3D-CT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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