Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

Study Overview
=================
Brief Summary
-----------------
Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital. Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.

Detailed Description
-----------------
This is a single center, prospective, randomized controlled pragmatic clinical trial designed to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or ureteral stones are planned to recruit for the study. All subjects will be computer sequence-randomized into having their ureteroscopic treatment performed with a disposable (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible ureteroscope. Patient's demographics, physical, laboratory, and image findings will be collected before surgery. These clinical data are already being collected as part of an ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue and need for a second ureteroscope during the case will be recorded during the treatment course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. The following surgical treatment will be used similarly for all three randomized arms and represents standard of case therapy: Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a holmium YAG laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved. After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the end of the procedure to drain the kidney for 2-21 days if it is clinically indicated. The total duration of the study is expected to be one year for subject recruitment and one year and six months for final subject follow-up.

Official Title
-----------------
Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone

Conditions
-----------------
Kidney Calculi, Ureter Calculi

Intervention / Treatment
-----------------
* Device: reusable fiberoptic ureteroscope
* Device: disposable digital ureteroscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years of age at their first clinical visit. Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging Patients being able and willing to provide consent. Exclusion Criteria: Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome. Pregnancy. Staged ureteroscopic procedure. Antegrade flexible ureteroscopy. Dual procedures (ureteroscopy concurrently performed with other operations).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: reusable fiberoptic ureteroscope<br>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. | Device: reusable fiberoptic ureteroscope<br>* We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.<br>|
| Experimental: disposable digital ureteroscope<br>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. | Device: disposable digital ureteroscope<br>* We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Procedure Time |  | at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Are Stone Free | this will be determined by either CT, US, or KUB | three month after surgery | 
| Number of Participants With Complications |  | from during the surgery to three months after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ureteroscopy, flexible ureteroscope, randomized controlled trial