Which is Better: Narrow vs. Wide Focus for Shock Wave Lithotripsy of Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
研究概览
简要总结
This study aims to compare the narrow focus (F1) versus the wide focus (F3) in terms of the efficacy of Shock Wave Lithotripsy (SWL) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.
详细描述
Recently, some Shock Wave Lithotripsy (SWL) devices have been announced in the market with a different focus points. One early experimental study found that stone disintegration is better with small focusing points than larger focusing points. Nevertheless, these findings, in terms of the efficacy of stone disintegration, need to be validated in-vivo. Furthermore, the effect of focal size on renal injury during SWL need to be studied as well. Therefore, the objectives of this study are to compare the effect of using the narrow focus of 2mm (F1) versus the wide focus of 8 mm (F3) on the Stone Free Rate (SFR) following SWL for renal stones 1-2cm and estimating renal injury effect of F1 vs. F3 by urinary renal injury markers such as neutrophil gelatinase-associated lipocalin (NGAL) for assessment of proximal and distal renal tubules injury & Kidney Injury Molecule-1 (KIM-1) for assessment of proximal renal tubules injury).
The SWL device:
Lithotripter type: Piezo Lith3000 plus ( from Richard Wolf, Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (>18years old) with 1-2 cm single renal stone.
- •Normal functioning kidney.
排除标准
- •Bleeding diatheses.
- •Radiolucent stones.
- •Radio-opaque stones with Hounsfield Unit (HU) > 1200
- •Patients with a pacemaker.
- •Active Urinary Tract Infection (UTI).
- •Severe skeletal malformations.
- •Morbid obesity with Body Mass Index (BMI) ≥40 kg/m
- •Renal artery aneurysm at the same site of the stone.
- •Anatomical obstruction distal to the stone.
- •Patients with renal impairment with serum creatinine > 1.2 mg/dL.
结局指标
主要结局
Assessment of efficacy of Shock Wave Lithotripsy (SWL) by calculation of the percentage (%) of stone free
时间窗: 1 year
Assessment of efficacy of Shock Wave Lithotripsy (SWL) and its success by calculation of stone free (%) following each session with a maximum of 3 Shock Wave Lithotripsy (SWL) sessions, 2 weeks a part, using pelvi-abdominal Ultrasound (US) and Kidney-Ureter-Bladder (KUB) and the presence of significant residual stone \>4 mm will be considered "non-stone free" and the final stone free status (%) will be calculated at one month following the last session of Shock Wave Lithotripsy (SWL). Shock Wave Lithotripsy (SWL) failure will be defined as failure to reach stone free status (%) one month after 3rd session.
次要结局
- Assessment of the degree of renal injury using renal injury markers(1 year)
- Assessment of the presence of peri-renal hematoma(1 year)
- Assessment of the changes in renal cortical thickness(1 year)
- Measurement of the changes in the Renal Resistive Index (RRI)(1 year)
研究者
Yasser A. Noureldin
Assistant Professor of Urology
Benha University