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RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
Sponsor: Changhai Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2025-04-01
Completion Date
2026-06-30
Last Updated
2025-07-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China