Estimation of Critical Stone Burden Requiring JJ Stent Before Extracorporeal Shockwave Lithotripsy Using 3D-CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Stone Volume by 3D-CT Volumetry
研究概览
简要总结
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..
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •BMI 18-30 kg/m²
- •Single radio-opaque renal stone 1-2 cm
- •Suitable for ESWL per clinical assessment
排除标准
- •Multiple renal stones
- •Solitary kidney
- •Impaired renal function
- •Congenital renal anomalies
- •Ureteric obstruction
- •Systemic comorbidities
- •Pregnancy
研究组 & 干预措施
ESWL without Initial JJ Stent
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)
干预措施: Extracorporeal shock wave lithotripter (Device)
结局指标
主要结局
Stone Volume by 3D-CT Volumetry
时间窗: 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
次要结局
- JJ Stent Necessity(2 weeks post-ESWL)
- ESWL Success Rate(2 weeks after maximum 2 ESWL sessions)
研究者
Hossam Elawady
Principal Investigator
Ain Shams University