Modified Mini-PCNL vs Standard PCNL for Complex 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 compares modified mini-percutaneous nephrolithotomy using a 20 Fr access sheath to standard PCNL using a 24 Fr sheath in adults with complex renal stones. Participants are about 1,380 patients at 8 urology centers who will be randomly assigned to one of the two procedures. Stone-free status is checked with a low-dose CT within 72 hours after surgery, with follow-up assessment at 3 months. The goal is to determine non-inferiority of the modified mini-PCNL in achieving stone clearance while potentially reducing surgical trauma and recovery burden. Additional outcomes include perioperative safety and recovery metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged ≥18 years.
2. Serum creatinine ≤133 μmol/L.
3. American Society of Anesthesiologists (ASA) physical status classification I-III.
4. S.T.O.N.E. score ≥8.
5. Complex renal stones confirmed by noncontrast computed tomography, including stone surface area \>1500 mm², multiple calyceal stones, partial or complete staghorn calculi, or complex anatomical conditions.
6. Patients who provide written informed consent and agree to undergo either modified mini-percutaneous nephrolithotomy or standard percutaneous nephrolithotomy.

Exclusion Criteria:

1. Solitary kidney.
2. Morbid obesity (body mass index ≥35 kg/m²).
3. Previous renal transplantation or urinary diversion.
4. Congenital abnormalities of the urinary tract.
5. Pregnancy.
6. Uncorrected coagulopathy.
7. Active urinary tract infection.

Where it's running

• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yongda Liu, Doctor
• Email: 13719007083@163.com
• Phone: +020-83062923

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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.