Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones

NCT07012941 | Not Yet Recruiting

• 1 other identifier: SYSKY-2024-050-01
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a relatively new technology. Through a multi-center prospective randomised clinical study that mainly aims to explore the effectiveness and safety of a super-pulsed fibre thulium laser compared to a holmium laser in the treatment of upper ureteral and renal stones (10mm\<cumulative maximum diameter ≤ 25mm) in retrograde intrarenal surgery. The research participants are assigned randomly to undergo retrograde intrarenal surgery (RIRS) either using a super-pulsed thulium fibre laser or a holmium-YAG laser with an allocation ratio of 1:1. The secondary aim of this study is to provide high-level evidence for the development of diagnostic and treatment guidelines in the field of urolithiasis, both domestically and internationally. The outcomes of the RIRS procedures are compared for the two treatment arms.

Conditions

Ureterolithiasis; Renal Calculi

Keywords

Super pulse thulium fiber laser (SPTFL); Ho:YAG laser; Lithotripsy; Ureteral Stone; Ureteroscopy; renal stone

Outcome Measures

Primary Outcomes (1)

• Stone-Free Rate at 4 Weeks Postoperative (Percentage of Participants)

  Urinary tract CT（Computed Tomography）scan at 4 weeks post-operative did not reveal residual stones or residual stones with a diameter ≤ 2 mm and no clinical symptoms were defined as stone clearance

  4 week post-operative

Secondary Outcomes (10)

• Intraoperative complication rate (Percentage of Participants)

  During the procedure

• Change in Hemoglobin from Baseline (g/dL)

  Within 24 hours postoperative

• Change in Serum Creatinine from Baseline (μmol/L)

  Within 24 hours postoperative

• Change in Blood Urea Nitrogen from Baseline (mmol/L)

  Within 24 hours postoperative

• Operative time (Minutes)

  Decided immediately after the surgery

Study Arms (2)

Superpulse Thulium Fiber laser (SPTFL)

ACTIVE COMPARATOR

With the help of a Superpuled Thulium Fibre laser machine, the ureteral or renal stones that are going to be treated with the RIRS procedure are either fragmented or dusted as part of the procedure.

Device: Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone

Holmium: YAG laser

ACTIVE COMPARATOR

With the help of a Holmium fibre laser machine, the ureteral or renal stones that are going to be treated with the RIRS procedure are either fragmented or dusted as part of the procedure.

Device: Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone

Interventions

Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone DEVICE

RIRS procedure for upper ureteral or renal stone lithotripsy with Superpulsed Thulium Laser

Superpulse Thulium Fiber laser (SPTFL)

Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone DEVICE

RIRS procedure for upper ureteral or renal stone lithotripsy with Holmium: YAG Laser

Holmium: YAG laser

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
• Patients who have been confirmed by bilateral renal/urinary tract CT to have upper ureteral or renal stones, single or multiple, and are planning to undergo ureteroscopic lithotripsy for stone removal;
• Confirmed by bilateral renal/urinary tract CT, the cumulative maximum diameter of stones is 10mm\<cumulative maximum diameter ≤ 25mm;
• Those who voluntarily participate and sign an informed consent form.

You may not qualify if:

• Uncontrollable systemic hemorrhagic disease;
• Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
• Uncontrolled urinary tract infections;
• Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
• Pregnant, planned pregnancy within 3 months, and lactating female patients;
• The patients determined by the investigator to be unsuitable for this study include (but are not limited to): known to have human immunodeficiency virus (HIV) or AIDS; Suffering from mental illness; Infectious diseases;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• RenJi Hospital: collaborator
• Tongji Hospital: collaborator
• West China Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Beijing Friendship Hospital: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Peking University Shenzhen Hospital: collaborator
• Shenzhen People's Hospital: collaborator

Study Sites (1)

Sun Yat sen Memorial Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (13)

• Wang W, Fan J, Huang G, Li J, Zhu X, Tian Y, Su L. Prevalence of kidney stones in mainland China: A systematic review. Sci Rep. 2017 Jan 31;7:41630. doi: 10.1038/srep41630.

  PMID: 28139722 BACKGROUND

• Khan SR, Pearle MS, Robertson WG, Gambaro G, Canales BK, Doizi S, Traxer O, Tiselius HG. Kidney stones. Nat Rev Dis Primers. 2016 Feb 25;2:16008. doi: 10.1038/nrdp.2016.8.

  PMID: 27188687 BACKGROUND

• Fried NM, Irby PB. Advances in laser technology and fibre-optic delivery systems in lithotripsy. Nat Rev Urol. 2018 Sep;15(9):563-573. doi: 10.1038/s41585-018-0035-8.

  PMID: 29884804 BACKGROUND

• Teichmann HO, Herrmann TR, Bach T. Technical aspects of lasers in urology. World J Urol. 2007 Jun;25(3):221-5. doi: 10.1007/s00345-007-0184-5. Epub 2007 May 30.

  PMID: 17534625 BACKGROUND

• Emiliani E, Kanashiro A, Angerri O. Lasers for stone lithotripsy: advantages/disadvantages of each laser source. Curr Opin Urol. 2023 Jul 1;33(4):302-307. doi: 10.1097/MOU.0000000000001092. Epub 2023 Mar 17.

  PMID: 36927702 BACKGROUND

• 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.

  PMID: 30729311 BACKGROUND

• Hale GM, Querry MR. Optical Constants of Water in the 200-nm to 200-microm Wavelength Region. Appl Opt. 1973 Mar 1;12(3):555-63. doi: 10.1364/AO.12.000555.

  PMID: 20125343 BACKGROUND

• Ventimiglia E, Doizi S, Kovalenko A, Andreeva V, Traxer O. Effect of temporal pulse shape on urinary stone phantom retropulsion rate and ablation efficiency using holmium:YAG and super-pulse thulium fibre lasers. BJU Int. 2020 Jul;126(1):159-167. doi: 10.1111/bju.15079. Epub 2020 May 18.

  PMID: 32277557 BACKGROUND

• Solano C, Corrales M, Panthier F, Candela L, Doizi S, Traxer O. Navigating urolithiasis treatment: assessing the practicality and performance of thulium fiber laser, holmium YAG, and thulium YAG in real-world scenarios. World J Urol. 2023 Oct;41(10):2627-2636. doi: 10.1007/s00345-023-04487-9. Epub 2023 Jul 20.

  PMID: 37468656 BACKGROUND

• Dorantes-Carrillo LA, Basulto-Martinez M, Suarez-Ibarrola R, Heinze A, Proietti S, Flores-Tapia JP, Esqueda-Mendoza A, Giusti G. Retrograde Intrarenal Surgery Versus Miniaturized Percutaneous Nephrolithotomy for Kidney Stones >1cm: A Systematic Review and Meta-analysis of Randomized Trials. Eur Urol Focus. 2022 Jan;8(1):259-270. doi: 10.1016/j.euf.2021.02.008. Epub 2021 Feb 21.

  PMID: 33627307 BACKGROUND

• Jiao B, Luo Z, Xu X, Zhang M, Zhang G. Minimally invasive percutaneous nephrolithotomy versus retrograde intrarenal surgery in surgical management of upper urinary stones - A systematic review with meta-analysis. Int J Surg. 2019 Nov;71:1-11. doi: 10.1016/j.ijsu.2019.09.005. Epub 2019 Sep 12.

  PMID: 31521837 BACKGROUND

• Li Z, Lai C, Shah AK, Xie W, Liu C, Huang L, Li K, Yu H, Xu K. Comparative analysis of retrograde intrarenal surgery and modified ultra-mini percutaneous nephrolithotomy in management of lower pole renal stones (1.5-3.5 cm). BMC Urol. 2020 Mar 16;20(1):27. doi: 10.1186/s12894-020-00586-6.

  PMID: 32178654 BACKGROUND

• 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.

  PMID: 33238763 RESULT

Related Links

• A SKOLARIKOS,A NEISIUS,A PETRIK,et al.EAU Guidelines on Urolithiasis,2022

MeSH Terms

Conditions

Ureterolithiasis; Kidney Calculi; Nephrolithiasis

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Kewei Xu, MD, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kewei Xu, MD, PhD

CONTACT

+86-13632331628; xukewei@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Prior to the surgery, it is necessary to select the surgical technique and follow the trial protocol by opening an envelope in the specified sequence. This trial protocol follows a "single blind" format, meaning that the researcher is aware of the surgical method while the subject remains unaware.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kewei Xu, MD, Ph.D

Model Details: Arm 1: Superpulse Thulium Fiber laser Arm 2: Holmium:YAG laser

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)