Safety and Efficacy of Fluoroscopy-free Technique During Retrograde Intrarenal Surgery for Renal Stones

Not Applicable

Recruiting

• Conditions: Kidney Calculi; Retrograde Intrarenal Surgery; Radiation Exposure
• Interventions: Procedure: Fluoroscopy-free RIRS; Procedure: Standard RIRS

• Registration Number: NCT05269108
• Lead Sponsor: Al-Azhar University

Brief Summary

Aiming to reduce radiation exposure to patients and physicians, the investigators conduct this study protocol to evaluate the possibility of performing retrograde intrarenal surgery (RIRS) under direct visualization without fluoroscopy. the investigators will prospectively evaluate the outcome of fluoroscopy-free RIRS for renal stones in comparison with the standard technique. The investigators expected that the fluoroscopy-free technique has high safety and efficacy even in complicated cases.

Detailed Description

With improved flexible URS instrumentation and lithotripsy technology, retrograde intrarenal surgery (RIRS) became an alternative and excellent option for renal stones. Fluoroscopy imaging may be necessary during various steps of RIRS, such as insertion of a guidewire and stent, access sheath insertion, detection of stone location and size, and assessment of collecting system anatomy.

In an effort to decrease radiation exposure, several studies were conducted to evaluate the possibility of performing RIRS under direct visualization without fluoroscopy. Most studies concluded that fluoroscopy-free RIRS is a feasible, effective, and safe technique. The reported stone-free rate ranged from 83.8% to 95.7%. No major complications were observed.

Despite the reported high safety and efficacy of the fluoroscopy-free RIRS technique, most of the studies were retrospective and included only uncomplicated cases, and none of the studies address its results against control.

In the present study, the investigators will prospectively evaluate the efficacy and safety of fluoroscopy-free RIRS for renal stones in comparison with fluoroscopy-guided technique as standard control. The study will include all patients with renal stones amenable to RIRS. The investigators expected that the fluoroscopy-free technique can deal with large stones and complex situations with high safety and success rate. The study hypothesis is that "the fluoroscopy-free technique has efficacy and safety similar to the fluoroscopy-guided technique".

The investigators also aim to determine the patients and surgical characteristics impacting the need for fluoroscopy. The intra-operative fluoroscopy imaging is expected to be necessary during RIRS, especially in complicated cases. In the fluoroscopic-free group, the fluoroscopic equipment will be available in the operating room and will be used if needed.

Study Timeline

• Study Start: 2022-02-25
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-02
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Renal stone.
• Stone size: ≥10 mm.

Exclusion Criteria

• Partial and complete staghorn stones.
• Pregnant women.
• Morbid obesity.
• Uncorrectable coagulation disorders.
• Active urinary tract infection (UTI).
• Stone in a calyceal diverticulum.
• Urinary tract obstruction distal to the stone.
• Concomitant pathology that needs intervention in the same setting.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopy-free RIRS	Fluoroscopy-free RIRS	Patients will be treated by RIRS without fluoroscopy
Standard RIRS	Standard RIRS	Standard RIRS under fluoroscopy-guidance will be performed

Primary Outcome Measures

Name	Time	Method
stone-free rate	3-months after the intervention.	defined as no residual stone or residual fragment(s) less than 4 mm (as confirmed by CT-UT).
complication rate	intraoperative till 3-months postoperative complications	intraoperative and postoperative complications

Secondary Outcome Measures

Name	Time	Method
Operative time	The procedure time	Time from induction of anesthesia till the end of the procedure
fluoroscopy time	intraoperative	intraoperative fluoroscopy imaging
the need for fluoroscopy	Intraoperative	The need for fluoroscopy imaging in a fluoroscopy-free group

Trial Locations

Locations (1)

Urology Department, Al-Azhar University Hospital; 🇪🇬 Cairo, Egypt