Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis (LiThuHol)

Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.

Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.

The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.

The costs and complications will also be studied.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Stone; Ureteral Stone
• Intervention / Treatment: Device: Ureteroscopy for upper tract stone treatment with Holmium laser; Device: Ureteroscopy for upper tract stone treatment with Thulium laser

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Pierre BIGOT, MD-PhD; Phone Number: +33 0241355830; Email: PiBigot@chu-angers.fr
• Study Contact Backup: Name: Bertrand DELBARRE, Resident; Phone Number: +33 0241353518; Email: Bertrand.Delbarre@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for ureteroscopy on renal or ureteral stones, which have been previously confirmed by tomography

Description

Inclusion Criteria:

• renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
• treatment with rigid or flexible ureteroscopy
• laser lithotripsy during the procedure
• bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)

Exclusion Criteria:

• non-use of laser for stone lithotripsy
• pregnant women
• under 18 years old
• refusal to give informed consent
• urinary malformation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Holmium laser lithotripsy; Stone fragmentation are performed with Holmium laser in ureteroscopy	Device: Ureteroscopy for upper tract stone treatment with Holmium laser; Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser
Thulium laser lithotripsy; Stone fragmentation are performed with Thulium laser in ureteroscopy	Device: Ureteroscopy for upper tract stone treatment with Thulium laser; Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.	Three months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	Recording data about ureteric perforation and bleeding	During the intervention
Operating time	All surgeries are included	Immediately after the intervention
Postoperative complications	Recording data according to the Clavien classification (rates of hospitalisation, pain, infection and surgical revision)	Up to three months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Publications and helpful links

General Publications

• Panthier F, Doizi S, Corrales M, Traxer O. Pulsed lasers and endocorporeal laser lithotripsy. Prog Urol. 2021 Jun-Jul;31(8-9):451-457. doi: 10.1016/j.purol.2020.11.008. Epub 2021 Jan 28.
• Martov AG, Ergakov DV, Guseinov MA, Andronov AS, Dutov SV, Vinnichenko VA, Kovalenko AA. [Initial experience in clinical application of thulium laser contact lithotripsy for transurethral treatment of urolithiasis]. Urologiia. 2018 Mar;(1):112-120. Russian.
• Rapoport LM, Vinarov AZ, Sorokin NI, Dymov AM, Enikeev DV, Tsarichenko DG, Lekarev VY, Klimov RE, Andreeva VA, Kovalenko AA. [Experimental verification of thulium lithotripsy]. Urologiia. 2018 Dec;(5):74-80. Russian.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis; Lithiasis
• Other Study ID Numbers: ar21-0020v0

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: Yes
• product manufactured in and exported from the U.S.: No