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

Study Overview
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Brief Summary
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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
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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. .

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

Conditions
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Ureteric Stone

Intervention / Treatment
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* Procedure: Ureteroscopic lithotripsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thulium-fibre laser (TFL)<br>The laser used in this group for surgical procedure ureteroscopic lithotripsy will be the Olympus SOLTIVETM Premium SuperPulsed laser system with a 365micron laser fibre. The laser pulse setting will be 1J x 10Hz, short pulse duration (adjusted up to 600microseconds). | Procedure: Ureteroscopic lithotripsy<br>* 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.<br>|
| Active Comparator: Holmium: yttrium-aluminum-garnet (Ho: YAG)<br>The laser used in this group for surgical procedure ureteroscopic lithotripsy will be the Lumenis VersaPulse® PowerSuiteTM 100W laser system with a 365micron laser fibre. The laser pulse setting will be 1J x 10Hz. Pulse duration is not adjustable in this machine (up to 600microseconds). | Procedure: Ureteroscopic lithotripsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficiency of stone ablation | Measured by stone ablation rate(pre-operative stone volume/ laser time) | Intraoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Duration of operation | Intra-operation | 
| Laser time | Duration of laser use | Intra-operation | 
| 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 | 
| 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 | 
| Stone free rate | Defined by no detectable stone on post-operative 3-month NCCT | 3 months post-operation | 
| Number of patients require auxiliary procedure after the intervention | Defined by any additional procedure | 3 months post-operation |