Flexible Ureteroscopy With Steerable Versus Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) Utility in Less Than 2cm Lower Pole Stones Treatment: a Multicenter, Randomized Superiority Trial (SCULPT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Success Rate of Lower Pole Navigation
研究概览
简要总结
This multicenter, randomized, controlled superiority trial (the SCULPT trial) aims to compare the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) versus the conventional FANS in the treatment of lower pole renal stones ≤2 cm. Lower pole stones are particularly challenging due to the narrow infundibular-pelvic anatomy that limits the maneuverability of standard FANS. The steerable FANS incorporates an active deflection mechanism that allows for independent control, potentially improving the success rate of accessing the lower pole calyx, performing laser lithotripsy, and aspirating stone fragments without additional adjuncts.
A total of 400 patients from 20 high-volume urological centers in China (approximately 20 patients per center) will be randomized in a 1:1 ratio to receive either steerable FANS or conventional FANS during flexible ureteroscopy. Primary outcome measures include the success rate of FANS navigation into the lower pole calyx as evidenced by direct stone visualization, effective laser lithotripsy, and successful stone aspiration. Secondary outcomes will assess immediate and 1-month stone-free rates, operative time, complication rates, instrument durability, and improvements in quality of life. This study is expected to provide critical evidence to guide clinical decision-making and potentially improve treatment efficiency for challenging lower pole renal stones.
详细描述
This trial is designed in response to the current challenges faced in the management of lower pole renal stones using flexible ureteroscopy, particularly when using conventional FANS. The narrow calyceal angles and complex lower pole anatomy can impede the passage of the access sheath, thereby limiting the efficiency of stone fragmentation and clearance. The innovative steerable FANS overcomes these limitations by offering an independent, active deflection mechanism that facilitates a greater range of movement, thus optimizing the access to lower pole calyces.
Background and Objectives Lower pole stones are notoriously difficult to treat due to their anatomical position and the limited maneuverability of conventional ureteral access sheaths. The new steerable FANS, with its deflection lever at the distal handle, allows for active, independent adjustment under endoscopic guidance, which may result in a higher success rate of reaching the lower pole and more efficient stone clearance. The primary objective of this trial is to compare the success rate of FANS navigation into the lower pole renal calyx between the steerable and conventional devices. Secondary objectives include the evaluation of immediate (within 24 hours) and 1-month stone-free rates, operative time, length of hospital stay, usage of auxiliary devices (e.g., stone baskets), instrument damage rates, complication rates (graded by the Clavien-Dindo system), and the impact on patient quality of life (assessed via the Wisconsin Stone QoL questionnaire).
Study Design and Methods
Trial Type:
This is a multicenter, prospective, single-blind, superiority, randomized controlled trial.
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, Investigator, Outcomes Assessor)
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
- •Adults aged 18-75 years
- •Diagnosed with a single lower pole renal stone ≤2 cm by CT
- •American Society of Anesthesiology (ASA) score of 1-3
- •Ability to provide written informed consent
- •Willingness and ability to comply with trial procedures and follow-up
排除标准
- •Patients with urinary tract anatomical abnormalities (e.g., horseshoe kidney, ileal conduit)
- •Untreated urinary tract infection
- •Presence of multiple stones or stones located outside the lower pole
- •Absolute contraindications to flexible ureteroscopy
- •Inability to understand or complete trial documentation
结局指标
主要结局
Success Rate of Lower Pole Navigation
时间窗: Periprocedural (Day of Procedure)
This outcome is defined as the proportion of cases in which the FANS (either steerable or conventional) successfully navigates into the lower pole renal calyx. Success is evidenced by the ability to directly visualize the stone, perform effective laser lithotripsy, and aspirate stone fragments without requiring additional adjunctive devices.
次要结局
- Immediate Stone-Free Rate(Day 1)
- Final Stone-Free Rate(1 month)
- Operative Time(Periprocedural (Day of Procedure))
- Duration of Hospital Stay(Periprocedural (Day of Procedure through Discharge))
- Use of Adjunct Devices(Recorded during the procedure)
- Instrument Damage Rates(Periprocedural (Day of Procedure))
- Complication Rate(Up to 1 month)
- Quality of Life Improvement(Baseline and 1 month)
研究者
Guohua Zeng
Vice president
The First Affiliated Hospital of Guangzhou Medical University