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Safety and Effectiveness of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy for Staghorn Calculi

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 15, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Objective This study aims to evaluate the safety and efficacy of antegrade flexible ureteroscopy-assisted PCNL for the treatment of staghorn calculi, compared with standard PCNL. Methods This prospective, multicenter, randomized controlled trial plans to enroll 420 patients with staghorn calculi, randomly assigned into two groups: the experimental group (antegrade flexible ureteroscopy-assisted PCNL, n=210) and the control group (standard PCNL, n=210). The primary endpoint is stone-free rate (defined as no residual fragment ≥2 mm on postoperative CT). Secondary endpoints include operative time, number of percutaneous tracts, rate of secondary procedures, hemoglobin decrease, postoperative complications (Clavien-Dindo classification), and length of hospital stay. All patients will undergo CT evaluation on postoperative day 2. Subgroup analysis will be performed according to the number of stone branches (≥5 vs \<5).
Trial Details
NCT Number NCT07172373
Lead Sponsor Tianjin Medical University Second Hospital
Collaborators: Chinese PLA General Hospital, Tianjin Medical University General Hospital, Peking University People's Hospital, First Hospital of China Medical University, The Second Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, Beijing Tsinghua Changgeng Hospital, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital, Zhejiang University, School of Medicine, The Affiliated Hospital of Qingdao University, Wuhan TongJi Hospital
Conditions Urolithiasis, Renal Stones
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov