Superpulse thulium fiber versus holmium:YAG laser for breaking kidney and upper ureter stones during ureteroscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized controlled trial will enroll 136 adults (18–70) with CT-confirmed kidney or upper ureter stones 6–20 mm and randomize them 1:1 to flexible ureteroscopy (FURS) using either superpulse thulium fiber laser (sTFL) or holmium:YAG laser (Ho:YAG). Procedures are performed under general anesthesia and the primary outcome is stone-free rate at 3 months, defined as residual fragments <2 mm on CT. Secondary outcomes include operation time, intra- and postoperative complications graded by Clavien–Dindo, surgeon visual experience, and stone recurrence at 6 months. Participants will be monitored closely for adverse events throughout the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* The latest urine culture before surgery is negative
* Signed and dated informed consent indicating that the patient or his or her legal representative has been fully informed about the study and has consented to participate

Exclusion Criteria:

* 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.
* Severe heart or lung disease, malignancy and immune deficiency status
* Neurogenic bladder
* Failure to provide informed consent
* Have an untreated urinary tract infection
* The presence of known anatomic abnormalities (such as ureteral stenosis), urothelial tumors, or stones that can be removed directly without the use of laser lithotripsy
* Pregnant women
* In cases where the stone cannot be reached with a bendable negative pressure suction sheath, or in cases where the stone cannot be reached with a conventional sheath or the pyeloureteral junction
* Surgical completion under epidural anesthesia or lumbar anesthesia
* Recurrent stones due to genetic metabolic diseases

Where it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yi Shao — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Ruixuan Zhu
• Email: luluzhu2023@qq.com
• Phone: +86 13780820139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.