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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..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWL without Initial JJ Stent | Experimental | All 56 patients received standardized ESWL treatment using third-generation Dornier lithotripter (maximum 2 sessions, 2500 shock waves/session). No preoperative JJ stent placement. Stone volume assessed via dual methods: 3D-CT volumetry (voxel-based segmentation) and ellipsoid formula (greatest dimensions on NCCT). Follow-up at 2 weeks with KUB/ultrasound; JJ stent placed for complications (incomplete fragmentation, obstruction, Stein Strasse, infection) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock wave lithotripter | Device | ESWL delivered at 70-80 shocks/min, max 2500 shocks/session, voltage ramped to 90 kV. Stone localization via fluoroscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Stone Volume by 3D-CT Volumetry | 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 | Pre-ESWL baseline |
| Measure | Description | Time Frame |
|---|---|---|
| JJ Stent Necessity | Rate of JJ stent placement due to ESWL complications (incomplete fragmentation, obstruction, Stein Strasse, infection) | 2 weeks post-ESWL |
| ESWL Success Rate | Stone-free rate (complete clearance or asymptomatic fragments <4mm on KUB/ultrasound) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain Shams University | Cairo | Cairo Governorate | 1151 | Egypt |
No individual participant data (IPD) will be shared. Summary results are available in the publication and ClinicalTrials.gov results database.
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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All 56 patients underwent standardized ESWL protocol (Dornier lithotripter, 2 sessions max, no initial JJ stent) with dual stone volume assessment: 3D-CT volumetry (voxel-based segmentation) vs ellipsoid formula (greatest dimensions). Patients stratified post-hoc by outcomes: success without stenting (n=14) vs complications requiring stent (n=42). No randomization; single treatment arm with diagnostic comparison
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No masking was employed. This open-label study involved standardized ESWL treatment for all patients without initial JJ stent placement. Investigators, patients, and outcome assessors were fully aware of treatment protocol and imaging assessments (3D-CT volumetry vs ellipsoid formula). Post-hoc stratification by ESWL outcomes (success vs complications requiring stent) was performed without blinding
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| 2 weeks after maximum 2 ESWL sessions |
| D052801 | Male Urogenital Diseases |