Comparing Super Pulse Fiber Thulium Laser and Holmium Laser for Ureteral Stone Fragmentation During Ureteroscopy

Condition(s) studied

Investigational drug(s) / intervention(s)

Superpulse Thulium Fiber Laser (sTFL) Treatment: The 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: The 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.

Study summary

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

Primary outcome measure(s)

• Stone-free Rate — 3 months post-procedure
  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.

Trial sites (1)

More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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