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.
Kidney stones (renal calculi) are a common urological condition that can lead to pain, infection, and renal dysfunction. For renal stones measuring 2-3 cm, both retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) are recognized treatment options. Traditional RIRS is less invasive but may be associated with lower stone-free rates for larger stones. A newly developed tip-flexible suction access sheath (TFS-UAS) allows improved access to renal calyces, reduces intrarenal pressure, and enables efficient stone fragment evacuation through continuous suction. This study is a prospective, multicenter, randomized controlled trial designed to compare the effectiveness and safety of RIRS using the TFS-UAS versus standard PCNL in patients with unilateral renal stones measuring 2-3 cm. A total of 308 patients aged 18-80 years will be enrolled from four tertiary hospitals in China. Eligible participants will be randomized into two groups to receive either TFS-UAS-assisted RIRS or standard PCNL. The primary endpoint is the stone-free rate (SFR) at 3 months, assessed by CT scan. Secondary outcomes include postoperative infection rates, changes in hemoglobin and procalcitonin levels, hospital stay duration, and pain scores. This study aims to provide high-quality evidence to guide surgical decision-making in the management of medium-sized kidney stones and to evaluate the potential advantages of the new suction-assisted sheath in minimally invasive endourology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China
RECRUITINGStone-Free Rate (SFR)
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.
Time frame: 3 months postoperatively
Incidence of Postoperative Infection (SIRS Criteria)
Number and proportion of participants who develop postoperative systemic inflammatory response syndrome (SIRS), defined as meeting at least 2 of the following: Temperature \>38°C or \<36°C Heart rate \>90 bpm Respiratory rate \>20/min or PaCO2 \<32 mmHg WBC count \>12×10⁹/L or \<4×10⁹/L
Time frame: Within 72 hours postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
308