About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Superpulse Thulium Fiber Laser (sTFL) Treatment
- Holmium:YAG Laser (Ho:YAG) Treatment