Suction mini-percutaneous nephrolithotomy versus standard percutaneous nephrolithotomy for the management of 2–4 cm kidney stones: study protocol for an international, multicenter, parallel-group, noninferiority, randomized controlled trial - Report - MDSpire
Advertisement
Suction mini-percutaneous nephrolithotomy versus standard percutaneous nephrolithotomy for the management of 2–4 cm kidney stones: study protocol for an international, multicenter, parallel-group, noninferiority, randomized controlled trial
Clinical Report: Suction Mini-PCNL vs Standard PCNL for 2–4 cm Renal Stones
Overview
This international, multicenter randomized controlled trial protocol compares suction mini-percutaneous nephrolithotomy (mini-PCNL) with standard PCNL for treating 2–4 cm kidney stones. The study aims to establish whether suction mini-PCNL is noninferior to standard PCNL in terms of immediate postoperative stone-free rate and operative time.
Background
Percutaneous nephrolithotomy (PCNL) is the recommended first-line treatment for kidney stones larger than 2 cm. Mini-PCNL uses a smaller tract to reduce tract-related complications but may increase operative time and intrarenal pressure. Suction application in mini-PCNL may improve fragment removal efficiency and reduce infectious complications. High-level evidence comparing suction mini-PCNL to standard PCNL is currently lacking, prompting this noninferiority trial.
Data Highlights
The trial plans to enroll 960 adult patients with 2–4 cm renal stones, randomized 1:1 to suction mini-PCNL or standard PCNL. Primary outcomes include immediate postoperative stone-free rate (SFR) and operative time. Secondary outcomes are final SFR at 1 month, hospital stay length, postoperative complications, and quality of life. The noninferiority margin for SFR is set at -10%, with an assumed SFR of 83% for suction mini-PCNL and 86% for standard PCNL. Operative time noninferiority margin is -10 minutes, with a standard deviation of approximately 15 minutes.
Key Findings
PCNL is the first-line treatment for kidney stones >2 cm, but tract-related complications remain a concern.
Mini-PCNL reduces tract size but may increase operative time and intrarenal pressure, risking infectious complications.
Suction mini-PCNL may enhance stone fragment removal and maintain low intrarenal pressure.
Previous data show mini-PCNL has comparable stone-free rates and operative times to standard PCNL with less bleeding and pain.
This trial is designed to test if suction mini-PCNL is noninferior to standard PCNL in surgical efficiency and safety.
The study includes 960 patients across 20 international centers with rigorous randomization and blinding of patients and outcome assessors.
Clinical Implications
If suction mini-PCNL is proven noninferior to standard PCNL, it may offer a safer alternative with potentially fewer tract-related complications and infectious risks. Clinicians could consider suction mini-PCNL for managing 2–4 cm renal stones, balancing operative efficiency with patient safety. The trial’s results will inform evidence-based guidelines and surgical decision-making.
Conclusion
This well-designed international trial will provide high-level evidence on the comparative effectiveness and safety of suction mini-PCNL versus standard PCNL for 2–4 cm kidney stones. Its findings are anticipated to guide clinical practice and optimize patient outcomes.
References
International Guidelines and Prior Studies on PCNL and Mini-PCNL
Trial Protocol Authors, 2024 -- Comparison of Suction Mini-PCNL and Standard PCNL for 2–4 cm Renal Stones
by Wen Zhong, Kehua Jiang, Xuepei Zhang, Chi Ho Leung, Wei Zhu, Zhanping Xu, Guofu Pang, Zhongyi Sun, Fan Cheng, Jin Li, Jie Chen, Yuanwei Li, Houmeng Yang, Shulian Chen, Chuanxun Wu, Rui Jia, Jin Zhu, Jorge Gutierrez-Aceves, Emanuele Montanari, Shabir Almousawi, Iliya Saltirov, Marcin Popiolek, Albert Aquino, Giorgio Mazzon, Simon Choong, Haibo Xi, Steffi Kar Kei Yuen, Guohua Zeng
