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NCT Number: NCT07337954

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, 1151, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Stone Volume by 3D-CT Volumetry

    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

Secondary outcomes

  1. JJ Stent Necessity

    Time frame: 2 weeks post-ESWL

    Rate of JJ stent placement due to ESWL complications (incomplete fragmentation, obstruction, Stein Strasse, infection)

  2. ESWL Success Rate

    Time frame: 2 weeks after maximum 2 ESWL sessions

    Stone-free rate (complete clearance or asymptomatic fragments <4mm on KUB/ultrasound)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Estimation of Critical Stone Burden Requiring JJ Stent Before Extracorporeal Shockwave Lithotripsy Using 3D-CT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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