RecruitingNot Applicable

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

China308 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 80 years
✓. American Society of Anesthesiologists (ASA) physical status classification of I-III
✓. Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
✓. Signed written informed consent and willingness to comply with study procedures

Exclusion criteria

✕. Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
✕. Uncontrolled urinary tract infection
✕. Absolute contraindications for RIRS or PCNL
✕. Inability to understand or complete study documentation
✕. Failure to follow study protocol or attend follow-up
✕. Patients requiring urgent rescue or at high risk for irreversible harm during surgery
✕. Patients who voluntarily withdraw from the study

What they're measuring

Stone-Free Rate (SFR)

Timeframe: 3 months postoperatively

Trial details

NCT IDNCT07058402

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Xiaofeng Gao

+86-21-13601600968 gxfdoc@sina.com

View on ClinicalTrials.gov More Nephrolithiasis trials