The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a relatively new technology. Through a multi-center prospective randomised clinical study that mainly aims to explore the effectiveness and safety of a super-pulsed fibre thulium laser compared to a holmium laser in the treatment of upper ureteral and renal stones (10mm\<cumulative maximum diameter ≤ 25mm) in retrograde intrarenal surgery. The research participants are assigned randomly to undergo retrograde intrarenal surgery (RIRS) either using a super-pulsed thulium fibre laser or a holmium-YAG laser with an allocation ratio of 1:1. The secondary aim of this study is to provide high-level evidence for the development of diagnostic and treatment guidelines in the field of urolithiasis, both domestically and internationally. The outcomes of the RIRS procedures are compared for the two treatment arms.
18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
Patients who have been confirmed by bilateral renal/urinary tract CT to have upper ureteral or renal stones, single or multiple, and are planning to undergo ureteroscopic lithotripsy for stone removal;
Confirmed by bilateral renal/urinary tract CT, the cumulative maximum diameter of stones is 10mm<cumulative maximum diameter ≤ 25mm;
Those who voluntarily participate and sign an informed consent form.
Uncontrollable systemic hemorrhagic disease;
Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
Uncontrolled urinary tract infections;
Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
Parallel
Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone
DeviceRIRS procedure for upper ureteral or renal stone lithotripsy with Superpulsed Thulium Laser
Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone
DeviceRIRS procedure for upper ureteral or renal stone lithotripsy with Holmium: YAG Laser
Stone-Free Rate at 4 Weeks Postoperative (Percentage of Participants)
Urinary tract CT（Computed Tomography）scan at 4 weeks post-operative did not reveal residual stones or residual stones with a diameter ≤ 2 mm and no clinical symptoms were defined as stone clearance
Intraoperative complication rate (Percentage of Participants)
Includes ureteral or renal pelvis perforation, mucosal avulsion, ureteral rupture, conversion to other treatments, and success rate of ureteral access sheath insertion.
Change in Hemoglobin from Baseline (g/dL)
Hemoglobin measured before and within 24 hours after surgery
Change in Serum Creatinine from Baseline (μmol/L)
Serum creatinine measured before and within 24 hours after surgery
Change in Blood Urea Nitrogen from Baseline (mmol/L)
BUN measured before and within 24 hours after surgery
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
RenJi Hospital
Collaborator
Tongji Hospital
Collaborator
West China Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Beijing Friendship Hospital
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Peking University Shenzhen Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
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