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

Kidney Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269108
• Other study ID #: Uro_Azhar_2_022
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Al-Azhar University
• Contact: Abul-fotouh Ahmed, MD
• Phone: 00201001066756
• Email: abulfotouhahmed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Radiation Exposure
• Retrograde Intrarenal Surgery

Intervention

Procedure:
• Fluoroscopy-free RIRS
RIRS for renal stone under direct visualization, without fluoroscopy
• Standard RIRS
RIRS for renal stone under fluoroscopy-guidance

Locations

Country	Name	City	State
Egypt	Urology Department, Al-Azhar University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	complication rate	intraoperative and postoperative complications	intraoperative till 3-months postoperative complications
Secondary	fluoroscopy time	intraoperative fluoroscopy imaging	intraoperative
Secondary	Operative time	Time from induction of anesthesia till the end of the procedure	The procedure time
Secondary	the need for fluoroscopy	The need for fluoroscopy imaging in a fluoroscopy-free group	Intraoperative