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临床试验/NCT07559214
NCT07559214尚未招募不适用

Flexible and Navigable Access Sheath (FANS) VS Direct in Scope Suction (DISS) in Treatment of Renal Stone > 2 cm , Controlled Randomized Trial

Assiut University0 个研究点目标入组 100 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Operative time

研究概览

简要总结

To compare between FANS & DISS in :

  • Operative time
  • Stone free rate
  • Complications
  • Amount of fluid irrigation

详细描述

Retrograde intrarenal surgery (RIRS) has revolutionized the management of renal stones, yet achieving high stone-free rates (SFR) while maintaining low intrarenal pressure (IRP) remains a challenge. Elevated IRP during irrigation is linked to post-operative complications, including systemic inflammatory response syndrome and renal parenchymal damage. To mitigate these risks, suction-assisted technologies have emerged as vital adjuncts to traditional flexible ureteroscopy (FURS).The Flexible and Navigable Access Sheath (FANS) represents a significant evolution in this field. Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency.For renal stones measuring less than 2 cm, both techniques aim to optimize the "perfusion-absorption" balance, effectively clearing stone dust and debris while preventing pyelovenous reflux. However, comparative data specifically for smaller stones remains limited. This study evaluates the clinical efficacy, safety profiles, and operative outcomes of FANS versus DISS in the treatment of renal calculi < 2 cm, aiming to determine which suction modality provides the most favorable balance of procedural efficiency and patient safety.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients < 18 years old presented with renal stone > 2cm whatever the site of the stone (pelvic or calyceal)

排除标准

  • Inaccessibility to introduce access sheath or FURS
  • Previous Inserted JJ stent
  • Active UTI
  • Patients refuse to participate in the protocol

研究组 & 干预措施

Flexible and navigable access sheath (FANS)

Experimental

In patients undergoing the FANS procedure , an access sheath with a bendable tip and aspiration feature will be placed into the relevant ureter up to the renal pelvis over the guidewire. The single-use flexible scope will be passed through the access sheath, and the renal collecting system. After this maneuver, the tip of the placed access sheath will be pushed into the renal calyces or pelvis under the guidance of the flexible URS and a holmium fiber will be used to pulverize the stones with a 273-µm fiber. In this group, stones were disintegrated (fragmented) into an adequate size (< 3 mm) to allow an efficient extraction with the help of active aspiration, finished by insertion of JJ in all patients.

干预措施: Flexible ureteroscopy (Procedure)

Direct in scope suction (DISS)

Experimental

In the DISS group, a single-use flexible URS with a direct in-scope suction system will be introduced over the placed guidewire and navigated into the renal pelvis without the use of an access sheath. The suctioning port on the ureteroscope and the laser fiber operates via the same port. In this group, the dusting preset of the same laser device will be used to disintegrate the stones. While continuous irrigation was applied to ensure optimum visualization, finished by insertion of JJ in all patients

干预措施: Flexible ureteroscopy (Procedure)

结局指标

主要结局

Operative time

时间窗: <60 minutes

The operative time is the duration of surgical procedure

次要结局

未报告次要终点

研究者

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

Armia Ezzat Thabet Azer

resident physician

Assiut University

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