Suction-assisted flexible RIRS versus PCNL for 2–3 cm kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Changhai Hospital, Naval Medical University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaofeng Gao
• Email: gxfdoc@sina.com
• Phone: +86-21-13601600968

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Suction vs Conventional Ureteral Access Sheaths in Kidney Stone Surgery

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• Observation vs Upfront Surgery for Asymptomatic Kidney Stones in Children and Adults

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• Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)

  This trial will test whether actively suctioning the kidney's collecting system at the end of RIRS reduces early postoperative pain and infections for adults having kidney stone removal.

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• Early versus delayed shock wave treatment for leftover kidney stones after percutaneous nephrolithotomy

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• Compare two suction ureteroscope devices for kidney stones (FANS vs CVAC)

  This study tests whether two new suction-enabled ureteroscopes (FANS and CVAC) lead to better stone clearance for adults with small to medium kidney stones compared to each other.

  Recruiting Ohio State University · Columbus, Ohio · NCT07514351

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.