The goal of this prospective, multicenter, randomized controlled trial is to objectively evaluate the clinical efficacy and safety differences between superpulse thulium fiber laser (sTFL) and holmium:YAG laser (Ho:YAG) in flexible ureteroscopy (FURS) lithotripsy in adult patients aged 18-70 years with kidney stones and/or upper ureteral stones (6-20mm). The main questions it aims to answer are:
Does sTFL yield a higher stone-free rate (SFR) compared to Ho:YAG at 3 months post-FURS? Is sTFL superior to Ho:YAG in terms of operation time, complication rate, and surgeon's visual experience during FURS? Researchers will compare the experimental group receiving sTFL treatment to the control group receiving Ho:YAG laser treatment to see if sTFL demonstrates better lithotripsy efficiency, safety, and ease of operation.
Participants aged 18-70 years will:
Undergo FURS lithotripsy under general anesthesia using either sTFL (experimental group) or Ho:YAG laser (control group) based on randomization Have CT scans at 3 months post-operation to assess stone-free status Be monitored for intraoperative and postoperative complications Have surgeons rate their visual experience during the procedure in terms of visual clarity, lithotripsy efficiency, stone movement and tissue injury
Age ≥18 years old
Diagnosis of kidney stones and/or upper ureteral stones with stone diameter ≥6mm and ≤20mm
Plan to undergo fURS lithotripsy
General anesthesia to complete the operation
Isolated kidney
Previous history of kidney transplantation or urinary diversion surgery
Congenital malformations of urinary system
Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
Patients aged 18-70 years who plan to undergo fURS lithotripsy for kidney stones and/or upper ureteral stones (6-20mm)
Cohort
Prospective
Superpulse Thulium Fiber Laser (sTFL) Treatment
DeviceThe superpulse thulium fiber laser (sTFL) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety.
Holmium:YAG Laser (Ho:YAG) Treatment
DeviceThe holmium:YAG laser (Ho:YAG) was used as a minimally invasive surgical treatment for kidney and upper ureteral stones. All procedures were performed by experienced urologists using standard techniques for laser lithotripsy. Laser settings, such as pulse energy and frequency, were adjusted according to stone characteristics and the surgeon's judgment to optimize treatment efficacy and safety.
Stone-free Rate
The proportion of participants achieving complete stone clearance, defined as no residual fragments or residual fragments ≤2 mm on follow-up imaging (e.g., plain radiography, ultrasound, or computed tomography) after a single laser lithotripsy procedure.
Operative Time
The duration of the surgical procedure, measured in minutes from the start of the operation until the completion of the surgical procedure. Operative times will be recorded and compared between the two groups.
Complication Rate
The proportion of participants experiencing complications during the surgical procedure and within 24 hours after the procedure. Complications will be recorded and classified according to the Clavien-Dindo system, which categorizes surgical complications by severity. The complication rates will be compared between the two groups.
Surgeon's Visual Experience
The surgeon's subjective assessment of visual clarity, stone fragmentation efficiency, stone movement, and tissue damage during the procedure. Recording the subjective feelings of urologists.
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