跳至主要内容
临床试验/NCT05460559
NCT05460559招募中不适用

Endoscopic Combined Intrarenal Surgery Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
2
主要终点
One stage stone free rate

研究概览

简要总结

The aim of this study is to compare outcomes of endoscopic combined intrarenal surgery (ECIRS) with the multi-tract percutaneous nephrolithotomy for management of complex renal stones.

详细描述

Nephrolithiasis is a very common disease and continues to be a common cause of morbidity. The evolving epidemiology of this disease includes changes in gender distribution and associations with systemic disease. The currently available modalities for the treatment of renal calculi include extracorporeal shockwaves lithotripsy (SWL), flexible ureteroscopy (FURS) and percutaneous nephrolithotomy (PCNL).

Complex renal stones usually refer to multiple stones, stones associated with anatomical or functional abnormalities or staghorn calculi. They can cause severe morbidities such as renal failure, sepsis, and even death. Rassweiler et al. defined complex renal calculi based on stone burden and distribution, renal function and associated infection. Due to the complicated etiological factors, large stone burdens, high operation risks and high recurrence, it is always a challenge for surgeons to treat such stones. Complete stone clearance is the ultimate goal in staghorn calculi management because of the high incidence of recurrence and its inherent risks to the kidney and life of the patient.

Various management options are available for management of staghorn renal calculi including PCNL monotherapy, single-tract PCNL with flexible nephroscopy, multi-tract PCNL, combinations of PCNL and SWL, SWL monotherapy and open surgical options.

The American Urological Association (AUA) guidelines recommend PCNL as the first-line treatment for staghorn calculi. According to the European Association of Urology (EAU) guidelines, SWL remains the method of choice for the removal of stones within the renal pelvis, upper or middle calices measuring < 2 cm while larger stones (more than 2 cm) and lower pole stones more than 1.5 cm should be managed using PCNL.

It is noteworthy that prone position is conventionally used for PCNL surgical procedure, which facilitates percutaneous renal puncture and decreases the chance of splanchnic injury. However, it confines the application of Endoscopic Combined Intra-Renal Surgery (ECIRS). Scoffone CM et al. reported the use of ECIRS in Galdakao-Modified Supine Valdivia (GMSV) position for complex urolithiasis, the results showed that ECIRS in GMSV position generated high one step SFR, without additional procedure related complications.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' age ≥ 18 years.
  • Patients who are diagnosed as complex renal calculi (Guy's Stone Score (GSS) 3 or 4) as detected by Non-contrast Computed Tomography (NCCT).

排除标准

  • Renal anatomic anomalies.
  • Solitary kidney.
  • Coagulation disorders.
  • Skeletal deformity.
  • Active urinary tract infection.

结局指标

主要结局

One stage stone free rate

时间窗: first post-operative day

It will include the one-stage SFR which is defined as the number of patients who will show no residual stones or only residual stone fragments \< 4 mm in diameter at postoperative day-1 assessment NCCT

次要结局

  • Number of percutaneous access tracts required.(during the procedure)
  • Postoperative complications(30 days after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Abdel-Lateif El-Sawy

Lecturer of Urology

Mansoura University

研究点 (2)

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