RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones

Condition(s) studied

Investigational drug(s) / intervention(s)

Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath: Participants undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath. The procedure involves the insertion of a flexible ureteroscope through the urethra and ureter into the kidney. A novel access sheath with tip-flexible and suction capabilities is used to facilitate stone fragmentation and removal. The goal is to improve stone clearance and reduce intrarenal pressure during the procedure.

Standard Percutaneous Nephrolithotomy (PCNL): Participants undergo standard percutaneous nephrolithotomy (PCNL). The procedure involves creating a percutaneous tract into the renal collecting system under imaging guidance, followed by nephroscope insertion to fragment and extract 2-3 cm renal stones. This represents the current standard of care for large renal calculi.

Study summary

This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.

Eligibility

Primary outcome measure(s)

• Stone-Free Rate (SFR) — 3 months postoperatively
  The proportion of participants who are stone-free after the procedure, defined as no residual stones or residual fragments \<2 mm based on postoperative plain abdominal X-ray or non-contrast CT scan.

Trial sites (1)

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