Clinical trial NCT07012941: Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones
Official title: An Application of Super-pulsed TFL vs Ho:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureter and Renal Stones: A Multi-center Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ureterolithiasis
Renal Calculi
Keywords: Super pulse thulium fiber laser (SPTFL)
Ho:YAG laser
Lithotripsy
Ureteral Stone
Ureteroscopy
renal stone
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Tongji Hospital
name: West China Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Renmin Hospital of Wuhan University
name: Beijing Friendship Hospital
name: Second Affiliated Hospital of Guangzhou Medical University
name: Beijing Tsinghua Changgeng Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Peking University Shenzhen Hospital
name: Shenzhen People's Hospital
First posted: 2025-06-10
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Superpulse Thulium Fiber laser Arm 2: Holmium:YAG laser
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Endoscopic surgery is the predominant method for treating urinary tract stones. The field of surgery has progressed from traditional open procedures and percutaneous lithotripsy to more advanced techniques such as mini, micro, and ureteroscopy methods. RIRS, which stands for retrograde intrarenal surgery, is a therapeutic option for upper ureteric or renal stones that are less than 2cm. Although various energy systems have been employed for stone fragmentation during ureteroscopy, laser energy is the predominant method used for this purpose. Both domestic and foreign criteria recommend the holmium laser. The thermal effects of the Ho:YAG laser efficiently pulverise stones. As a result, it is currently the most widely used laser for conducting laser lithotripsy on stones in the urinary tract. Unfortunately, the holmium-YAG laser system has some intrinsic problems, such as different components having varying effects. 2. During the fragmentation process, the stone displacement is large and difficult to accurately control. 3. Some stones cannot be powdered, heat-damaged, or perforated. 4. Mucosal damage during fragmentation makes it easy to bleed and ooze. 5. The powdering efficiency is low, the fragmentation time is long, there is a lower energy conversion ratio, excessive heat generation in machines, noise, etc. Thus, clinical practice requires a new laser technology to overcome the holmium laser's limitations.

Thus, new laser systems are being created to fix the issue. The newest laser technology, super-pulsed thulium fiber laser (SPTFL), has promising results. A super-pulse fibre thulium laser is a pulsed fibre thulium laser that can be clinically used for lithotripsy. In 2005, in vitro experiments related to super-pulsed fibre thulium laser lithotripsy were first reported. Experimental data suggests that, compared with holmium laser, thulium laser has the following advantages in urinary tract stone lithotripsy: 1. TFL has higher lithotripsy efficiency, and the stone ablation speed is 1.5-4 times faster than that of Ho:YAG. 2. A safer lithotripsy with a 4-fold reduction in penetration depth and a limited temperature increase inside the cavity (up to 39 °C). 3. Lower costs: low maintenance costs, low fibre damage, low equipment volume (1/8), high energy conversion. Subsequently, an increasing number of in vitro experiments and clinical studies have been conducted internationally. However, there is a scarcity of studies in the literature that directly compare the effectiveness and stone free rates of the Holmium-YAG laser and SPTFL systems. Consequently, investigators are interested in conducting a formal multi-center prospective randomised clinical study to compare the two systems in RIRS.

Eligibility criteria: Inclusion Criteria:

1. 18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
2. 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;
3. Confirmed by bilateral renal/urinary tract CT, the cumulative maximum diameter of stones is 10mm\<cumulative maximum diameter ≤ 25mm;
4. Those who voluntarily participate and sign an informed consent form.

Exclusion Criteria:

1. Uncontrollable systemic hemorrhagic disease;
2. Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
3. Uncontrolled urinary tract infections;
4. Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
5. Pregnant, planned pregnancy within 3 months, and lactating female patients;
6. The patients determined by the investigator to be unsuitable for this study include (but are not limited to): known to have human immunodeficiency virus (HIV) or AIDS; Suffering from mental illness; Infectious diseases;

Primary outcomes:
measure: Stone-Free Rate at 4 Weeks Postoperative (Percentage of Participants)
timeFrame: 4 week post-operative
Secondary outcomes:
measure: Intraoperative complication rate (Percentage of Participants)
timeFrame: During the procedure
measure: Change in Hemoglobin from Baseline (g/dL)
timeFrame: Within 24 hours postoperative
measure: Change in Serum Creatinine from Baseline (μmol/L)
timeFrame: Within 24 hours postoperative
measure: Change in Blood Urea Nitrogen from Baseline (mmol/L)
timeFrame: Within 24 hours postoperative
measure: Operative time (Minutes)
timeFrame: Decided immediately after the surgery
measure: Lithotripsy time (Minutes)
timeFrame: intra-operation
measure: Length of Hospital Stay (Days)
timeFrame: up to 30 days
measure: Total hospitalization costs
timeFrame: Up to 3 months
measure: Postoperative Complications (Clavien-Dindo Classification, Percentage of Participants)
timeFrame: Up to 30 days post-operative
measure: Number of Additional Staged Procedures (Count per Participant)
timeFrame: Up to 3 months post-operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat sen Memorial Hospital of Sun Yat sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Kewei Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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