Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone
  • Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone

Treatment groups

448 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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