Ureteric Stone
Conditions
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. .
Interventions
PROCEDUREUreteroscopic lithotripsy
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for the outcomes are blinded from the allocated treatment arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficiency of stone ablation | Intraoperation | Measured by stone ablation rate(pre-operative stone volume/ laser time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laser time | Intra-operation | Duration of laser use |
| Length of hospital stay | 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 |
| Operation time | Intra-operation | Duration of operation |
| Stone free rate | 3 months post-operation | Defined by no detectable stone on post-operative 3-month NCCT |
| Number of patients require auxiliary procedure after the intervention | 3 months post-operation | Defined by any additional procedure |
| Number of patient with Complications after surgical procedure | 30 days post-operation | Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Countries
Hong Kong
Outcome results
None listed