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

Summary

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).

Conditions

• Urolithiasis
• Renal Stones

Interventions

PROCEDURE

antegrade flexible ureteroscopy-assisted PCNL

antegrade flexible ureteroscopy-assisted PCNL

PROCEDURE

single PCNL

single PCNL

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• Tianjin Medical University Second Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-03-30

Completion

2026-04-30