Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy for the Treatment of Renal Calculi < 3 cm - Efficacity Prospective Randomized Multicentre Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 主要终点
- Stone clearance
研究概览
简要总结
This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.
详细描述
Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.
However, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution.
Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach.
This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent and indicated a willingness to comply with study treatments
- •Subject has a diagnosis of renal stones according to computer tomography (CT) and intravenous pyelogram (IVP) results
- •Subject is a surgical candidate for the ureteroscopic approach
- •Subject is 18-80 yrs of age
- •Subject has a single stone < 3 cm in size (IVP), or multiple stones < 3 cm in cumulative size (IVP)
- •Subject has a serum creatinine level within the normal range for the study center
排除标准
- •Subject needs bilateral procedures within one-stage ureteroscopy
- •Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
- •Subject has been diagnosed with a urethral stricture or bladder neck contracture
- •Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
- •Subject has severe hematuria that might blur the vision of the endoscopy
- •Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
- •Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
- •Subject has other diseases and could not tolerate the endoscopic surgery
- •Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
- •Subject has ipsilateral pre-stenting or previous ureteroscopy within six months
- •Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination
结局指标
主要结局
Stone clearance
时间窗: 12 weeks post-operatively
Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group \*100%
次要结局
- Stone clearance(One day post-operatively)
- Complication rates(Within 12 weeks after surgery)
- Endoscope deflection loss rates(intraoperative)
- Endoscope Leakage rates(intraoperative)
- Endoscope black dots rates(intraoperative)
研究者
Ling Li, MD
Chief of Department of Urology
Changhai Hospital