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

NCT ID: NCT04346485

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2022-05-31

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.

Conditions

Kidney Stone; Nephrolithiasis; Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SP TFL RIRS with 145 mcm fiber

Superpulse thulium fiber laser RIRS with 145 mcm laser fiber

Group Type: EXPERIMENTAL

SP TFL RIRS with 145 mcm fiber

Intervention Type: PROCEDURE

retrograde intrarenal surgery

SP TFL RIRS with 200 mcm fiber

Superpulse thulium fiber laser RIRS with 200 mcm laser fiber

Group Type: EXPERIMENTAL

SP TFL RIRS with 200 mcm fiber

Intervention Type: PROCEDURE

retrograde intrarenal surgery

Ho:YAG RIRS with 200 mcm fiber

Ho:YAG laser RIRS with 200 mcm laser fiber

Group Type: ACTIVE_COMPARATOR

Ho:YAG RIRS with 200 mcm fiber

Intervention Type: PROCEDURE

retrograde intrarenal surgery

Interventions

SP TFL RIRS with 145 mcm fiber

retrograde intrarenal surgery

Intervention Type: PROCEDURE

SP TFL RIRS with 200 mcm fiber

retrograde intrarenal surgery

Intervention Type: PROCEDURE

Ho:YAG RIRS with 200 mcm fiber

retrograde intrarenal surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dmitry Enikeev, MD, PhD

Deputy director for research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Facility Contacts

Dmitry Enikeev, MD

Role: primary

enikeev-dv@1msmu.ru

+7 925 517 79 26

Other Identifiers

Sechenov-RIRS-20

Identifier Type: -

Identifier Source: org_study_id