RecruitingNot ApplicableNCT07058402

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

A Multicenter, Randomized Controlled Trial Comparing the Retrograde Intrarenal Surgery With a Tip-Flexible Suction Access Sheath to the Standard Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Unilateral Renal Stones

Sponsor

Changhai Hospital

Enrollment

308 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Nephrolithiasis

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria7

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

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Interventions

PROCEDURERetrograde 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.

PROCEDUREStandard 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.