3D-CT vs Ellipsoid for JJ Stent Prediction Before ESWL

NCT07337954 | Completed

• 1 other identifier: FMASU MS872024
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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..

Conditions

Urolithiasis; Shock Wave Lithotripsy; Ureteral Stents

Keywords

stone volume; 3D-CT, volumetry; stent necessity; stone burden

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• JJ Stent Necessity

  2 weeks post-ESWL

• ESWL Success Rate

  2 weeks after maximum 2 ESWL sessions

Study Arms (1)

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)

Device: Extracorporeal shock wave lithotripter

Interventions

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.

ESWL without Initial JJ Stent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• BMI 18-30 kg/m²
• Single radio-opaque renal stone 1-2 cm
• Suitable for ESWL per clinical assessment

You may not qualify if:

• Multiple renal stones
• Solitary kidney
• Impaired renal function
• Congenital renal anomalies
• Ureteric obstruction
• Systemic comorbidities
• Pregnancy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, 1151, Egypt

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)