Comparison of Limited Fluoroscopy and Conventional URSL

NCT07788612 | Completed

• 1 other identifier: UW 17-178
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ureteric stone; limited-fluoroscopy ureteroscopic lithotripsy

Outcome Measures

Primary Outcomes (1)

• Total intraoperative radiation exposure in limited-fluoroscopy versus conventional URSL

  Intraoperative

Secondary Outcomes (5)

• Success rate of limited-fluoroscopy URSL

  Intraoperative

• Operative time

  Intraoperative

• Intraoperative and postoperative complications

  Intraoperative and up to 30 days postoperatively

• Stone-free rate

  At 4 weeks postoperatively

• Need for auxiliary procedures

  Up to 3 months postoperatively

Study Arms (2)

Limited-Fluoroscopy URSL

EXPERIMENTAL

Patients undergo ureteroscopic lithotripsy with fluoroscopy reserved for safety backup only. Guidewire insertion, endoscopic advancement, stone fragmentation, and ureteric stent placement are performed under direct endoscopic visualization and tactile feedback. Stand-by fluoroscopy is available at the operating surgeon's discretion. Upon completion, a limited retrograde pyelogram is performed to exclude extravasation and confirm stent position.

Procedure: Ureteroscopic Lithotripsy

Conventional Fluoroscopy-Guided URSL

ACTIVE COMPARATOR

Patients undergo ureteroscopic lithotripsy with routine fluoroscopy employed at standard procedural steps: during guidewire insertion, endoscopic advancement, stone fragmentation, and ureteric stent placement. A completion retrograde pyelogram is routinely performed to look for contrast extravasation or ureteric perforation.

Procedure: Ureteroscopic Lithotripsy

Interventions

Ureteroscopic Lithotripsy PROCEDURE

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

Also known as: Holmium laser lithotripsy, Endoscopic stone fragmentation, URSL

Conventional Fluoroscopy-Guided URSL; Limited-Fluoroscopy URSL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older who decided for URSL as the treatment for ureteric stone

You may not qualify if:

• Patients who are unable to consent
• No stone upon ureteroscopy
• Known ureteric stricture or complicated ureteral anatomy
• Stone in solitary kidney
• Bilateral ureteric stones

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (20)

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MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start: August 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 26, 2026

Record last verified: 2016-08

Locations

HK (1)