Skip to main content
Clinical Trials/NCT06489366
NCT06489366
Not yet recruiting
Not Applicable

Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial

Zhongnan Hospital1 site in 1 country138 target enrollmentJune 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
Zhongnan Hospital
Enrollment
138
Locations
1
Primary Endpoint
Stone-free rate (SFR)
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.

Detailed Description

The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.

Registry
clinicaltrials.gov
Start Date
June 26, 2024
End Date
February 26, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zhongnan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥18 years old;
  • patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery;
  • patients who volunteered to participate in this study.

Exclusion Criteria

  • Unable to give informed consent;
  • Untreated urinary tract infection;
  • Pregnant women;
  • Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);
  • Urothelial tumors, transplanted kidney stones, irreversible coagulopathy;
  • The semi-rigid ureteroscope cannot reach the stone site, ureteroscopy-negative stones, and stones can be removed directly without laser lithotripsy;
  • The researchers believe that they are not suitable for participation in this study.

Outcomes

Primary Outcomes

Stone-free rate (SFR)

Time Frame: 2-4 weeks after surgery

Stone-free rate (SFR) after single-session laser lithotripsy using a semirigid ureteroscope without an auxiliary procedure assessed by CT/X-ray at 2-4 weeks follow-up after laser lithotripsy.

Secondary Outcomes

  • Intraoperative complications(Immediately during surgery)
  • Operative time(Immediately during surgery)
  • Postoperative complications(2-4 weeks after surgery)
  • Additional procedures(Intraoperatively and before removal of the Ureteral stents)

Study Sites (1)

Loading locations...

Similar Trials