Suction-assisted flexible RIRS versus PCNL for 2–3 cm kidney 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
This study will test whether a suction-assisted flexible RIRS removes 2–3 cm kidney stones as effectively and safely as standard PCNL in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07058402 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial will enroll 308 adults with a single 2–3 cm kidney stone and randomize them to either retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath (TFS-UAS) or standard percutaneous nephrolithotomy (PCNL). The TFS-UAS is designed to improve access to renal calyces, reduce intrarenal pressure, and evacuate stone fragments by continuous suction to potentially increase stone clearance during RIRS. The primary endpoint is stone-free rate at 3 months measured by CT, and secondary outcomes include postoperative infection rates, changes in hemoglobin and procalcitonin, hospital stay duration, and pain scores. Procedures and follow-up will be carried out at four tertiary centers in China with standardized protocols.
Who should consider this trial
Good fit: Adults aged 18–80 with a single unilateral kidney stone measuring 2–3 cm on CT, ASA I–III, who can give informed consent and comply with follow-up are ideal candidates.
Not a fit: Patients with abnormal urinary tract anatomy, uncontrolled urinary infection, absolute contraindications to RIRS or PCNL, urgent surgical needs, or inability to follow the protocol are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, suction-assisted RIRS could offer a less invasive way to clear medium-sized kidney stones with similar or fewer complications and shorter hospital stays compared with PCNL.
How similar studies have performed: PCNL is an established effective treatment for 2–3 cm stones while conventional RIRS has shown lower stone-free rates for larger stones; suction-assisted sheaths are a novel modification with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 80 years 2. American Society of Anesthesiologists (ASA) physical status classification of I-III 3. Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan 4. Signed written informed consent and willingness to comply with study procedures Exclusion Criteria: 1. Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit) 2. Uncontrolled urinary tract infection 3. Absolute contraindications for RIRS or PCNL 4. Inability to understand or complete study documentation 5. Failure to follow study protocol or attend follow-up 6. Patients requiring urgent rescue or at high risk for irreversible harm during surgery 7. Patients who voluntarily withdraw from the study
Where this trial is running
Shanghai, Shanghai Municipality
- Changhai Hospital, Naval Medical University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaofeng Gao
- Email: gxfdoc@sina.com
- Phone: +86-21-13601600968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.