North District Hospital
Sheung Shui, Hong Kong
NCT Number: NCT05218057
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sheung Shui, Hong Kong
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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Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Intraoperation
Measured by stone ablation rate(pre-operative stone volume/ laser time)
Time frame: Intra-operation
Duration of operation
Time frame: Intra-operation
Duration of laser use
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
Time frame: 30 days post-operation
Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 3 months post-operation
Defined by no detectable stone on post-operative 3-month NCCT
Time frame: 3 months post-operation
Defined by any additional procedure
Chinese University of Hong Kong
Other
TFL vs Ho:YAG - A Prospective Study to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy
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