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

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).

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	2025-10-01
Primary Completion	2026-03-30 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-15