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 - Summary - MDSpire

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

  • 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

  • February 26, 2026

  • 0 min

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Objective:

To determine whether suction mini-PCNL is noninferior to standard PCNL in terms of surgical efficiency, specifically focusing on primary outcomes such as stone-free rate (SFR) and operative time in the management of 2–4 cm kidney stones.

Key Findings:
  • SFRs for suction mini-PCNL and standard PCNL are reported as 83% and 86%, respectively, indicating comparable effectiveness.
  • Noninferiority margin for SFR is set at -10%, suggesting a clinically acceptable difference.
  • Operative times for suction mini-PCNL are assumed to be noninferior to standard PCNL, pending trial results.
Interpretation:

The study aims to provide high-level evidence on the efficacy and safety of suction mini-PCNL compared to standard PCNL for larger kidney stones, potentially influencing treatment guidelines.

Limitations:
  • Potential for bias due to lack of surgeon blinding.
  • Generalizability may be limited to participating centers.
  • Selection bias may occur if eligible patients are not uniformly approached.
Conclusion:

This trial will clarify the role of suction mini-PCNL in treating 2–4 cm renal stones and its comparative effectiveness to standard PCNL, paving the way for future research and clinical practice improvements.

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