Overview
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.
Description
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.
Eligibility
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