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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Changhai Hospital
- Enrollment
- 308
- Locations
- 1
- Primary Endpoint
- Stone-Free Rate (SFR)
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath
Participants in this group will undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath for the treatment of 2-3 cm unilateral renal stones.
Intervention: Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath (Procedure)
Standard Percutaneous Nephrolithotomy (PCNL)
Participants in this group will undergo standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones.
Intervention: Standard Percutaneous Nephrolithotomy (PCNL) (Procedure)
Outcomes
Primary Outcomes
Stone-Free Rate (SFR)
Time Frame: 3 months postoperatively
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.
Secondary Outcomes
- Incidence of Postoperative Infection (SIRS Criteria)(Within 72 hours postoperatively)