Clinical trial NCT05218057: to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy
Official title: TFL vs Ho:YAG - A Prospective Study to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteric Stone
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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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Eligibility criteria: 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

Primary outcomes:
measure: The efficiency of stone ablation
timeFrame: Intraoperation
Secondary outcomes:
measure: Operation time
timeFrame: Intra-operation
measure: Laser time
timeFrame: Intra-operation
measure: Length of hospital stay
timeFrame: The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure
measure: Number of patient with Complications after surgical procedure
timeFrame: 30 days post-operation
measure: Stone free rate
timeFrame: 3 months post-operation
measure: Number of patients require auxiliary procedure after the intervention
timeFrame: 3 months post-operation
Other outcomes:
Locations:
city: Sheung Shui
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
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