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

Not Applicable

• Conditions: Kidney Stone; Urolithiasis; Nephrolithiasis
• Interventions: Procedure: SP TFL RIRS with 200 mcm fiber; Procedure: SP TFL RIRS with 145 mcm fiber

• Registration Number: NCT04346485
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-12
• Study Start: 2020-03-13
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SP TFL RIRS with 200 mcm fiber	SP TFL RIRS with 200 mcm fiber	Superpulse thulium fiber laser RIRS with 200 mcm laser fiber
SP TFL RIRS with 145 mcm fiber	SP TFL RIRS with 145 mcm fiber	Superpulse thulium fiber laser RIRS with 145 mcm laser fiber

Primary Outcome Measures

Name	Time	Method
Laser-on time	during surgery	Time of laser emission during surgery, seconds

Secondary Outcome Measures

Name	Time	Method
Operative time	during surgery	Surgery duration, minutes
adverse events	during surgery and 6 months after surgery	Complications according to Clavien-Dindo classification (higher score means more severe complication)
Stone-free rate	3 month	Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT
Catheter stay	1 week	duration of catheterisation, days
Radiation exposure	during surgery	Effective dose, mSv
Hemoglobin drop	1 day after surgery	Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L
hospitalization length	1 week	Duration of hospital stay after surgery, days

Trial Locations

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University.; 🇷🇺 Moscow, Russian Federation