Laser Lithotripsy During URS - Holmium vs Thulium

Study Overview
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Brief Summary
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The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser. The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser. The outcomes of the URS procedures are compared for the two treatment arms.

Detailed Description
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The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total. Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting. The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser. The outcomes of the URS procedures are compared for the two treatment arms.

Official Title
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Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety

Conditions
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Urolithiasis

Intervention / Treatment
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* Device: Holmium:YAG laser machine
* Device: Thulium Fiber laser machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway Exclusion Criteria: Known pathology of the upper urinary tract Untreated infection

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
Interventional Model Description: Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Holmium:YAG laser machine<br>The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine. | Device: Holmium:YAG laser machine<br>* Ureteroscopy with Holmium:YAG laser lithotripsy<br>|
| Experimental: Thulium Fiber laser machine<br>The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine. | Device: Thulium Fiber laser machine<br>* Ureteroscopy with Thulium Fiber laser lithotripsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments. | 3 months after the URS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Surgical operating time | Decided immediately after the surgery | 
| Intraoperative complications | Intraoperative complications leading to abruption of the URS procedure | Decided immediately after the surgery | 
| Postoperative complications | Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure. | Within 3 months post endoscopically | 
| Postoperative JJ-stenting | How many needed postendoscopic stunting following the URS procedure | Decided immediately after the surgery |