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Comparison of Limited Fluoroscopy and Conventional URSL
Sponsor: The University of Hong Kong
Summary
Background: Ureteroscopic lithotripsy (URSL) is the standard treatment for ureteric stones. Conventional URSL employs routine fluoroscopy for guidewire positioning, scope advancement, stent placement, and complication detection. While facilitating the procedure, this approach exposes patients and operating theatre staff to ionizing radiation, with attendant long-term health risks and occupational hazards from lead apron use. Retrospective and prospective case series have suggested that URSL can be performed safely with limited or no fluoroscopy using direct endoscopic visualization and tactile feedback. However, no randomized controlled trial has directly compared the stone clearance rates and radiation exposure between these two approaches. Purpose: This two-center prospective randomized controlled trial aims to evaluate the feasibility and radiation exposure of limited-fluoroscopy URSL and to compare its complication profile, operative outcomes, and stone-free rates against conventional fluoroscopy-guided URSL. Study question: Does a limited-fluoroscopy protocol significantly reduce intraoperative radiation dose without compromising the success rate, safety, or operative efficiency of ureteroscopic lithotripsy? Methods: A total of 60 adult patients (≥18 years) with ureteric stones scheduled for URSL will be randomized in a 1:1 ratio to either the limited-fluoroscopy arm (fluoroscopy used only at surgeon's discretion for safety, with primary reliance on endoscopic landmarks) or the conventional arm (routine fluoroscopy throughout the procedure). The primary endpoint is radiation exposure (mGy). Secondary endpoints include stone-free rate at follow-up, operative time, intraoperative and postoperative complications, and need for auxiliary procedures.
Official title: Comparison of Limited Fluoroscopy Ureteroscopic Lithotripsy Against Conventional Ureteroscopic Lithotripsy, a 2 Center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2016-08-01
Completion Date
2017-07-31
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Ureteroscopic Lithotripsy
Surgical procedure performed under general or regional anaesthesia using a semi-rigid or flexible ureteroscope to access the ureteric stone. Stone fragmentation is achieved using a holmium:YAG laser with energy settings determined by stone composition and size. Fragments may be retrieved using endoscopic baskets or forceps. Ureteric stent placement and retrograde pyelography are performed as clinically indicate
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong