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OpenTrials
Completed

NCT Number: NCT05218057

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North District Hospital

Sheung Shui, Hong Kong

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ureteroscopic lithotripsy

Procedure

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.

Primary outcomes

  1. The efficiency of stone ablation

    Time frame: Intraoperation

    Measured by stone ablation rate(pre-operative stone volume/ laser time)

Secondary outcomes

  1. Operation time

    Time frame: Intra-operation

    Duration of operation

  2. Laser time

    Time frame: Intra-operation

    Duration of laser use

  3. Length of hospital stay

    Time frame: The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure

    Total number of days of hospitalization for the surgical procedure

  4. Number of patient with Complications after surgical procedure

    Time frame: 30 days post-operation

    Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  5. Stone free rate

    Time frame: 3 months post-operation

    Defined by no detectable stone on post-operative 3-month NCCT

  6. Number of patients require auxiliary procedure after the intervention

    Time frame: 3 months post-operation

    Defined by any additional procedure

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2022
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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