Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

I.M. Sechenov First Moscow State Medical University

Status: Unknown

Conditions: Urolithiasis; Kidney Stone; Nephrolithiasis

Treatments: Procedure: SP TFL RIRS with 200 mcm fiber; Procedure: SP TFL RIRS with 145 mcm fiber; Procedure: Ho:YAG RIRS with 200 mcm fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT04346485

Sechenov-RIRS-20

Details and patient eligibility

About

The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:

• decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
• increasing the flexible ureteroscope tip deflection lower pole stones availability;
• decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
• increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter

Full description

RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days.

A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and Females > 18 y.o.;
• Radiologically confirmed (CT) kidney stone;
• Stone size from 10 to 20 mm.

Exclusion criteria

• Multiple (more than 3) kidney stones > 5 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

SP TFL RIRS with 145 mcm fiber

Experimental group

Description:

Superpulse thulium fiber laser RIRS with 145 mcm laser fiber

Treatment:

Procedure: SP TFL RIRS with 145 mcm fiber

SP TFL RIRS with 200 mcm fiber

Experimental group

Description:

Superpulse thulium fiber laser RIRS with 200 mcm laser fiber

Treatment:

Procedure: SP TFL RIRS with 200 mcm fiber

Ho:YAG RIRS with 200 mcm fiber

Active Comparator group

Description:

Ho:YAG laser RIRS with 200 mcm laser fiber

Treatment:

Procedure: Ho:YAG RIRS with 200 mcm fiber