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

Urolithiasis Clinical Trial

Official title:

Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04346485
• Other study ID #: Sechenov-RIRS-20
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Urolithiasis

Intervention

Procedure:
• SP TFL RIRS with 145 mcm fiber
retrograde intrarenal surgery
• SP TFL RIRS with 200 mcm fiber
retrograde intrarenal surgery
• Ho:YAG RIRS with 200 mcm fiber
retrograde intrarenal surgery

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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