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

Safety and Efficacy of Fluoroscopy-free Technique During Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized, Non-inferiority Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Calculi; Radiation Exposure; Retrograde Intrarenal Surgery
• Intervention / Treatment: Procedure: Fluoroscopy-free RIRS; Procedure: Standard RIRS

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 Type: Interventional
• Enrollment (Anticipated): 520
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Urology Department, Al-Azhar University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoroscopy-free RIRS; Patients will be treated by RIRS without fluoroscopy	Procedure: Fluoroscopy-free RIRS; RIRS for renal stone under direct visualization, without fluoroscopy
Active Comparator: Standard RIRS; Standard RIRS under fluoroscopy-guidance will be performed	Procedure: Standard RIRS; RIRS for renal stone under fluoroscopy-guidance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fluoroscopy time	intraoperative fluoroscopy imaging	intraoperative
Operative time	Time from induction of anesthesia till the end of the procedure	The procedure time
the need for fluoroscopy	The need for fluoroscopy imaging in a fluoroscopy-free group	Intraoperative

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: Uro_Azhar_2_022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No