Purpose <p>The optimal treatment for 2–3&#xa0;cm renal stones requires balancing efficacy with minimal invasiveness. While mini-percutaneous nephrolithotomy (mPCNL) is a standard approach, retrograde intrarenal surgery with a Flexible and Navigable Suction Sheath (FANS-RIRS) has emerged as a promising alternative. We conducted a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of these two procedures.</p> Methods <p>A systematic search of PubMed, Embase, Web of Science, and CENTRAL was conducted through August 2025 to identify RCTs comparing FANS-RIRS and mPCNL for 2–3&#xa0;cm renal stones. Primary outcomes included stone-free rates (SFRs), perioperative variables, and safety profiles, including hemorrhagic and infectious complications. Evidence was synthesized using random-effects models, and certainty was assessed with the GRADE framework.</p> Results <p>Three high-quality RCTs enrolling 1020 patients were included. Final SFRs were comparable between FANS-RIRS and mPCNL (OR 0.80, 95% CI 0.51–1.24; <i>P</i> = 0.31). However, FANS-RIRS was associated with significant advantages in safety and recovery, including a smaller hemoglobin decline (MD − 5.36&#xa0;g/L), lower rates of hemorrhage (OR 0.08) and blood transfusion (OR 0.14), a shorter hospital stay (MD − 1.75 days), and less postoperative pain (all <i>P</i> &lt; 0.05). Operative time, auxiliary procedure rates, and infectious complications did not differ significantly between groups. The certainty of evidence for outcomes was rated as moderate to low due to the small number of studies and heterogeneity.</p> Conclusion <p>Current evidence from randomized trials suggests that for 2–3&#xa0;cm renal stones, FANS-RIRS may provide efficacy comparable to mPCNL but with a potentially superior safety profile and faster patient recovery. While promising, these findings are based on a limited number of RCTs, and FANS-RIRS appears to be a viable option, particularly for patients who have a high bleeding risk or prioritize a quicker return to normal activities.</p> Trial registration number <p>This study was prospectively registered in PROSPERO (CRD420251136058).</p>

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Efficacy and safety of retrograde intrarenal surgery with a flexible and navigable suction sheath (FANS-RIRS) versus mini-percutaneous nephrolithotomy (mPCNL) for 2–3 cm renal stones: a systematic review and meta-analysis of randomized controlled trials

  • Yulong Li,
  • Zhuoyue Yao,
  • Zhongbao Zhou,
  • Hanchuan Wang,
  • Yong Zhang,
  • Huantao Zong

摘要

Purpose

The optimal treatment for 2–3 cm renal stones requires balancing efficacy with minimal invasiveness. While mini-percutaneous nephrolithotomy (mPCNL) is a standard approach, retrograde intrarenal surgery with a Flexible and Navigable Suction Sheath (FANS-RIRS) has emerged as a promising alternative. We conducted a meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of these two procedures.

Methods

A systematic search of PubMed, Embase, Web of Science, and CENTRAL was conducted through August 2025 to identify RCTs comparing FANS-RIRS and mPCNL for 2–3 cm renal stones. Primary outcomes included stone-free rates (SFRs), perioperative variables, and safety profiles, including hemorrhagic and infectious complications. Evidence was synthesized using random-effects models, and certainty was assessed with the GRADE framework.

Results

Three high-quality RCTs enrolling 1020 patients were included. Final SFRs were comparable between FANS-RIRS and mPCNL (OR 0.80, 95% CI 0.51–1.24; P = 0.31). However, FANS-RIRS was associated with significant advantages in safety and recovery, including a smaller hemoglobin decline (MD − 5.36 g/L), lower rates of hemorrhage (OR 0.08) and blood transfusion (OR 0.14), a shorter hospital stay (MD − 1.75 days), and less postoperative pain (all P < 0.05). Operative time, auxiliary procedure rates, and infectious complications did not differ significantly between groups. The certainty of evidence for outcomes was rated as moderate to low due to the small number of studies and heterogeneity.

Conclusion

Current evidence from randomized trials suggests that for 2–3 cm renal stones, FANS-RIRS may provide efficacy comparable to mPCNL but with a potentially superior safety profile and faster patient recovery. While promising, these findings are based on a limited number of RCTs, and FANS-RIRS appears to be a viable option, particularly for patients who have a high bleeding risk or prioritize a quicker return to normal activities.

Trial registration number

This study was prospectively registered in PROSPERO (CRD420251136058).