Are Extracorporeal Shock Wave Lithotripsy and Mini-Percutaneous Nephrolithotomy Equivalent in The Management of Pediatric High-Density Renal Stones? A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
Pediatric nephrolithiasis is an increasing health problem, with rising prevalence particularly in certain geographic regions. Management options for pediatric renal stones include extracorporeal shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL), and retrograde intrarenal surgery. According to the EAU/ESPU guidelines, SWL is recommended as a first-line treatment for most renal stones; however, its success is significantly influenced by stone size, location, and density. High-density renal stones (≥1000 Hounsfield Units) are associated with lower stone-free rates after SWL and higher retreatment rates.
Miniaturized percutaneous nephrolithotomy (mini-PNL) has emerged as an effective alternative, offering high stone-free rates with reduced morbidity compared to standard PNL due to the use of smaller access sheaths. While adult studies have demonstrated superior outcomes of mini-PNL over SWL for high-density renal stones, there is a lack of comparative data in the pediatric population.
This prospective randomized controlled study aims to compare the efficacy and safety of mini-PNL versus SWL in children aged 2 to 12 years with single, non-lower pole, high-density (≥1000 HU), medium-sized (10-20 mm) renal stones. Eligible patients will be randomized into two equal groups to undergo either mini-PNL or SWL under general anesthesia.
The primary outcome is the stone-free rate, defined as no residual stone or residual fragments ≤4 mm on non-contrast computed tomography performed three months after the procedure. Secondary outcomes include operative and fluoroscopy times, hemoglobin drop, length of hospital stay, retreatment and ancillary procedure rates, and postoperative complications graded according to the Clavien-Dindo classification.
The study will be conducted at a single tertiary referral center. All participants' parents or legal guardians will provide informed consent in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. This study aims to provide evidence to guide optimal management of pediatric patients with high-density renal stones.
详细描述
INTRODUCTION:
While nephrolithiasis is far more common in adults, pediatric stone disease is increasing in prevalence, especially in adolescent females , with higher incidences in the Middle East and North Africa and less common in North America and Europe . The management of pediatric upper urinary tract stones includes extracorporeal shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL), and retrograde intrarenal surgery (RIRS).
SWL is a non-invasive procedure that can be performed in children. The European Association of Urology and European Society for Pediatric Urology (EAU/ESPU) guidelines recommend SWL as the primary treatment option for majority of renal stones and upper ureter stones. The stone-free rate (SFR) is significantly affected by various factors; stone location, size and density. Also, presence and degree of obstruction/impaction, and stone-to-skin distance affect SFR. SWL has SFR of nearly 90% for stones <1 cm, 80% for 1-2 cm, 60% for >2 cm. Concerns about anaesthesia and high retreatment rate represent SWL drawback .
The EAU/ESPU guidelines recommend PNL as a mainline of treatment in renal stones larger than 2 cm in the renal pelvis or more than 1 cm in lower pole stone as well as staghorn stones , as the SFR of PNL is between 86.9% and 98.5% after a single session, even in complete staghorn cases, it has a clearance rate of 89%. The PNL complications in children include bleeding, postoperative fever or infection, and persistent urinary leakage. With the miniaturised PNL (mini-PNL) through a 16-18F sheath, the transfusion rates and complications decreased.
The EAU/ESPU guidelines recommended SWL as a primary treatment for renal pelvis, 10-20 mm . However, some authors reported that SWL in children was more successful for stones with HU <1000.Also, in another recent study for adult patients with single, non-lower pole, high-density (≥1000 HU) renal stones, the SFR was 97.1% in the mini-PNL group versus 30.3% in the SWL group .
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from ages 2 to 12
- •Single renal stone pelvic, upper or middle calyceal
- •Stone diameter between 1 and 2 cm in the longest axis by NCCT
- •High-density (≥1000 HU) by NCCT
排除标准
- •Radiolucent stones
- •Co-existing renal anomalies
- •Uncorrectable bleeding disorders
- •Musculoskeletal deformities
- •Patients with ureteral stones or ureteral obstruction