ESWL vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study

ConditionStone Ureter
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

This comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. A thorough understanding of these techniques is essential for optimizing patient outcomes and personalizing treatment strategies.

study aim to evaluate the effectiveness, safety, and cost of SWL compared to flexible uretroscopy in management patients with upper ureteric stone less than 15 mm in size

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients age>18 years old. Stone site: upper ureteric stone. Stone side: unilateral stones Stone size: stones diameter up to 1cm Stone number: single or multiple Radio-opaque stone

Disqualifiers

patients with solitary kidney or only function kidney renal impairment present of distal obstruction pregnancy, current breast feeding. Bleeding tendency or anticoagulation. ipsilateral ureterolithiasis, Acute or chronic nephritis, or Renal tuberculosis aneurysm of the aorta or renal artery. inability to position the patient on the SWL table (eg, due to severe skeletal deformity or morbid obesity).

Trial design

Design model

Parallel

Treatments tested in this trial

  • shock wave lithotripsy

    Procedure/Surgery

    Extracorporeal shock wave lithotripsy will be performed using a third-generation electromagnetic lithotripter The focal depth is 110 mm; the focal area is 7 mm (radial) and 45-50 mm (axial), and the focal pressure is 6-30 MPa). The procedure is performed in a supine or prone position without anesthesia. Stone localization and simultaneous real-time monitoring during the process will be performed by ultrasound). The shock frequency is 60-90 (shock waves/min). The total number of shock waves applied for one session is between 1500 and 2500 waves, or the session is stopped at a significant stone fragmentation is detected. The voltage applied per session ranged from 10 to 16 kV with stepwise power ramping strategy. All procedures in the SWL group are outpatient procedures.

  • Flexible ureteroscope lithotripsy

    Procedure/Surgery

    All F-URS cases will be performed by a single surgeon (HMI). A guidewire is placed in the upper urinary tract through a rigid cystoscope under fluoroscopic guidance. An 8-10 F dual lumen catheter is used to dilate the intramural ureter and to fix a second guidewire with hydrophilic coat. The 7.5 F flexible ureteroscope is passed into the upper urinary tract in a monorail fashion over the second wire. A holmium-YAG laser is used at an energy setting of 0.8-1 J and a rate of 10-15 Hz. A 200 µm laser fibre is used for delivering laser energy to the stones. A 2.2 F tipless nitinol basket is used to displace the stones from the lower pole to an upper pole calyx before disintegration. Adequate fragmentation is considered when fragments are smaller than the diameter of the guide wire. Stone fragments will be left for spontaneous passage. At the end of the procedure, the whole collecting system will be inspected for residual stones and a double pigtail ureteric stent will be left for 2 weeks t

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: ESWL groupExperimental treatment 0 interventions
Group B: FURS groupExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

The stone-free rate (SFR)

The stone-free rate (SFR) is defined as no evidence of clinically significant stone fragments (≥ 4 mm in size) in combination with a plain X-ray of the urinary tract (KUB) and urinary ultrasound one month after SWL or F-URS

Time frame
1 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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