Superpulse thulium fiber versus holmium:YAG laser for breaking kidney and upper ureter stones during ureteroscopy
Comparison of Super Pulse Fiber Thulium Laser and Holmium Laser Lithotripsy Under Ureteroscopy
This trial tests whether the superpulse thulium fiber laser works better than the holmium:YAG laser for adults (18–70) having ureteroscopy to break 6–20 mm kidney or upper ureter stones.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06667557 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 with kidney or upper ureter stones measuring 6–20 mm who are scheduled for flexible ureteroscopy under general anesthesia.
Not a fit: Patients with a single kidney, untreated urinary infection, major urinary tract anatomic abnormalities, prior urinary diversion or transplant, or severe comorbid conditions are excluded and unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, sTFL could increase stone-free rates and shorten operating time, reducing the need for repeat procedures and lowering complication rates.
How similar studies have performed: Early clinical series and smaller randomized trials have shown promising improvements in dusting efficiency and operative time with sTFL, but large multicenter randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.