to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy

Ureteric Stone Clinical Trial

Official title:

TFL vs Ho:YAG - A Prospective Study to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218057
• Other study ID #: CRE 2021.652
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized clinical trial aimed to compare the difference in stone ablation rates of TFL and Ho:YAG laser in a clinical setting. Patients are randomized to receive URS with lithotripsy (URSL) either with TFL or Ho:YAG with an allocation ratio of 1:1. Primary outcome is the efficiency of stone ablation in terms of the stone ablation rate

Description:

Having the advantages of being minimally invasive and simple, ureteroscopic lithotripsy is one of the treatment options for ureteric stone less than 1.5 cm. While many energy systems has been used for stone fragmentation during ureteroscopy, laser energy is the most commonly used approach for stone fragmentation. Currently, Holmium-YAG laser is the main laser platform being used due to its preciseness and safety. Unfortunately, Holmium-YAG laser system has some intrinsic problems, such as lower energy conversion ratio, excessive heat generation in machines, noise etc. Therefore, newer laser systems are being developed to overcome the problem. Thulium-fiber Laser (TFL) is the latest available laser system in the market with promising results. The advantages of TFL included better energy conversion ratio, less heat energy generation, more portable size, allow the generation of higher laser frequency for better stone dusting etc. Therefore, its uses are increasing popular. However, there are not many studies comparing the efficacy and stone free results of the Holmium-YAG laser and TFL systems in the literature. Therefore, investigators would like to perform a formal study to compare the two systems.

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 30, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18-years-old with informed consent

Exclusion Criteria:

• Patients on anti-coagulation

• Patients with condition that increases the risk of urolithiasis (e.g. cystinuria, hyperparathyroidism, previous intestinal resection)

• Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)

• Patients with stones > 15 mm

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureteric Stone
• Ureterolithiasis

Intervention

Procedure:
• Ureteroscopic lithotripsy
Ureteroscopic lithotripsy is one of the surgical procedure options for ureteric stone less than 1.5 cm. While many energy systems has been used for stone fragmentation during ureteroscopy, laser energy is the most commonly used approach for stone fragmentation.

Locations

Country	Name	City	State
Hong Kong	North District Hospital	Sheung Shui

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (11)

Andreeva V, Vinarov A, Yaroslavsky I, Kovalenko A, Vybornov A, Rapoport L, Enikeev D, Sorokin N, Dymov A, Tsarichenko D, Glybochko P, Fried N, Traxer O, Altshuler G, Gapontsev V. Preclinical comparison of superpulse thulium fiber laser and a holmium:YAG laser for lithotripsy. World J Urol. 2020 Feb;38(2):497-503. doi: 10.1007/s00345-019-02785-9. Epub 2019 May 4. — View Citation

Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20. — View Citation

Fried NM. Recent advances in infrared laser lithotripsy [Invited]. Biomed Opt Express. 2018 Aug 30;9(9):4552-4568. doi: 10.1364/BOE.9.004552. eCollection 2018 Sep 1. — View Citation

Li JK, Teoh JY, Ng CF. Updates in endourological management of urolithiasis. Int J Urol. 2019 Feb;26(2):172-183. doi: 10.1111/iju.13885. Epub 2018 Dec 21. — View Citation

Martov AG, Ergakov DV, Guseynov M, Andronov AS, Plekhanova OA. Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. J Endourol. 2021 Jun;35(6):795-800. doi: 10.1089/end.2020.0581. Epub 2021 Jan 13. — View Citation

Saussine C, Andonian S, Pacik D, Popiolek M, Celia A, Buchholz N, Sountoulides P, Petrut B, de la Rosette JJMCH. Worldwide Use of Antiretropulsive Techniques: Observations from the Clinical Research Office of the Endourological Society Ureteroscopy Global Study. J Endourol. 2018 Apr;32(4):297-303. doi: 10.1089/end.2017.0629. Epub 2018 Jan 17. — View Citation

Sorokin I, Mamoulakis C, Miyazawa K, Rodgers A, Talati J, Lotan Y. Epidemiology of stone disease across the world. World J Urol. 2017 Sep;35(9):1301-1320. doi: 10.1007/s00345-017-2008-6. Epub 2017 Feb 17. — View Citation

Tae BS, Balpukov U, Cho SY, Jeong CW. Eleven-year Cumulative Incidence and Estimated Lifetime Prevalence of Urolithiasis in Korea: a National Health Insurance Service-National Sample Cohort Based Study. J Korean Med Sci. 2018 Jan 8;33(2):e13. doi: 10.3346/jkms.2018.33.e13. — View Citation

Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390. — View Citation

Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007/s00345-019-02654-5. Epub 2019 Feb 6. — View Citation

Ziemba JB, Matlaga BR. Epidemiology and economics of nephrolithiasis. Investig Clin Urol. 2017 Sep;58(5):299-306. doi: 10.4111/icu.2017.58.5.299. Epub 2017 Aug 10. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficiency of stone ablation	Measured by stone ablation rate(pre-operative stone volume/ laser time)	Intraoperation
Secondary	Operation time	Duration of operation	Intra-operation
Secondary	Laser time	Duration of laser use	Intra-operation
Secondary	Length of hospital stay	Total number of days of hospitalization for the surgical procedure	The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure
Secondary	Number of patient with Complications after surgical procedure	Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0	30 days post-operation
Secondary	Stone free rate	Defined by no detectable stone on post-operative 3-month NCCT	3 months post-operation
Secondary	Number of patients require auxiliary procedure after the intervention	Defined by any additional procedure	3 months post-operation