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Comparison of Limited Fluoroscopy and Conventional URSL

NCT07788612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-26

No results posted yet for this study

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.

Conditions

  • Ureteric Stone

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2017-01-31
Completion
2017-07-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788612 on ClinicalTrials.gov