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

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

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

Study Overview

• Status: Recruiting
• Conditions: Nephrolithiasis; Urolithiasis; Kidney Stone
• Intervention / Treatment: Procedure: SP TFL RIRS with 145 mcm fiber; Procedure: SP TFL RIRS with 200 mcm fiber; Procedure: Ho:YAG RIRS with 200 mcm fiber

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 Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Institute for Urology and Reproductive Health, Sechenov University.
    • Contact: Dmitry Enikeev, MD; Phone Number: +7 925 517 79 26; Email: enikeev-dv@1msmu.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP TFL RIRS with 145 mcm fiber; Superpulse thulium fiber laser RIRS with 145 mcm laser fiber	Procedure: SP TFL RIRS with 145 mcm fiber; retrograde intrarenal surgery
Experimental: SP TFL RIRS with 200 mcm fiber; Superpulse thulium fiber laser RIRS with 200 mcm laser fiber	Procedure: SP TFL RIRS with 200 mcm fiber; retrograde intrarenal surgery
Active Comparator: Ho:YAG RIRS with 200 mcm fiber; Ho:YAG laser RIRS with 200 mcm laser fiber	Procedure: Ho:YAG RIRS with 200 mcm fiber; retrograde intrarenal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser-on time	Time of laser emission during surgery, seconds	during surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: RIRS; holmium laser; superpulse thulium laser; kidney stone disease
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Calculi; Urolithiasis; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: Sechenov-RIRS-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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