RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones

Launched by CHANGHAI HOSPITAL · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to treat kidney stones that are between 2 and 3 centimeters in size. One method is called retrograde intrarenal surgery (RIRS), which uses a special flexible tube with suction to help remove the stones through the urinary tract. The other method, percutaneous nephrolithotomy (PCNL), involves making a small cut in the back to remove the stones directly. The study aims to see which method is safer and more effective at completely clearing the stones.

If you are between 18 and 80 years old, have a single kidney stone of the right size confirmed by a CT scan, and are generally healthy enough for surgery, you might be eligible to join. Participants will be randomly assigned to one of the two treatment methods and will be closely followed to check how well the procedure works and to monitor any side effects. The study is currently recruiting patients at several centers in China. It’s important to know that people with certain urinary tract issues, infections, or who cannot follow the study rules would not be eligible. Joining this trial means you’ll get expert care and help doctors learn more about the best ways to treat medium-sized kidney stones.

Gender

ALL

Eligibility 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