Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

Renal Stone Clinical Trial

— LiThuHol  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04871984
• Other study ID #: ar21-0020v0
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: October 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Angers
• Contact: Pierre BIGOT, MD-PhD
• Phone: 0241355830
• Email: PiBigot[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2022
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lithiasis
• Renal Stone
• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis

Intervention

Device:
• Ureteroscopy for upper tract stone treatment with Holmium laser
Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser
• Ureteroscopy for upper tract stone treatment with Thulium laser
Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

References & Publications (3)

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. — View Citation

Panthier F, Doizi S, Corrales M, Traxer O. Pulsed lasers and endocorporeal laser lithotripsy. Prog Urol. 2021 Jan 27. pii: S1166-7087(20)30712-0. doi: 10.1016/j.purol.2020.11.008. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

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