Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

Study Overview
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Brief Summary
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The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows: decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.; increasing the flexible ureteroscope tip deflection lower pole stones availability; decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber; increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter

Detailed Description
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RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035) will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days. A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.

Official Title
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Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study

Conditions
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Kidney Stone, Nephrolithiasis, Urolithiasis

Intervention / Treatment
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* Procedure: SP TFL RIRS with 145 mcm fiber
* Procedure: SP TFL RIRS with 200 mcm fiber
* Procedure: Ho:YAG RIRS with 200 mcm fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females > 18 y.o.; Radiologically confirmed (CT) kidney stone; Stone size from 10 to 20 mm. Exclusion Criteria: • Multiple (more than 3) kidney stones > 5 mm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP TFL RIRS with 145 mcm fiber<br>Superpulse thulium fiber laser RIRS with 145 mcm laser fiber | Procedure: SP TFL RIRS with 145 mcm fiber<br>* retrograde intrarenal surgery<br>|
| Experimental: SP TFL RIRS with 200 mcm fiber<br>Superpulse thulium fiber laser RIRS with 200 mcm laser fiber | Procedure: SP TFL RIRS with 200 mcm fiber<br>* retrograde intrarenal surgery<br>|
| Active Comparator: Ho:YAG RIRS with 200 mcm fiber<br>Ho:YAG laser RIRS with 200 mcm laser fiber | Procedure: Ho:YAG RIRS with 200 mcm fiber<br>* retrograde intrarenal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser-on time | Time of laser emission during surgery, seconds | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Complications according to Clavien-Dindo classification (higher score means more severe complication) | during surgery and 6 months after surgery | 
| Operative time | Surgery duration, minutes | during surgery | 
| Hemoglobin drop | Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L | 1 day after surgery | 
| Catheter stay | duration of catheterisation, days | 1 week | 
| hospitalization length | Duration of hospital stay after surgery, days | 1 week | 
| Radiation exposure | Duration of X-ray exposure, sec. | during surgery | 
| Radiation exposure | Effective dose, mSv | during surgery | 
| Stone-free rate | Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RIRS, holmium laser, superpulse thulium laser, kidney stone disease