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

Not Applicable
Completed
Conditions
Ureteric Stone
Interventions
Procedure: Ureteroscopic lithotripsy
Registration Number
NCT05218057
Lead Sponsor
Chinese University of Hong Kong
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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Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
46
Inclusion Criteria
  • Patients older than 18-years-old with informed consent
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Thulium-fibre laser (TFL)Ureteroscopic lithotripsyThe 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).
Holmium: yttrium-aluminum-garnet (Ho: YAG)Ureteroscopic lithotripsyThe 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).
Primary Outcome Measures
NameTimeMethod
The efficiency of stone ablationIntraoperation

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

Secondary Outcome Measures
NameTimeMethod
Laser timeIntra-operation

Duration of laser use

Operation timeIntra-operation

Duration of operation

Length of hospital stayThe 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

Number of patient with Complications after surgical procedure30 days post-operation

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

Stone free rate3 months post-operation

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

Number of patients require auxiliary procedure after the intervention3 months post-operation

Defined by any additional procedure

Trial Locations

Locations (1)

North District Hospital

🇭🇰

Sheung Shui, Hong Kong

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