Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

Kidney stones that are large or complex are often treated with percutaneous nephrolithotomy, also called PCNL. Standard PCNL uses a larger access tract and is effective for removing complex kidney stones, but it may be associated with more bleeding, pain, and recovery burden. Modified mini-PCNL uses a smaller access tract and may reduce surgical trauma while maintaining a similar stone clearance rate.

This multicenter randomized trial will compare modified mini-PCNL using a 20 Fr access sheath with standard PCNL using a 24 Fr access sheath in adults with complex renal stones. About 1,380 participants from 8 urology centers will be randomly assigned to receive one of the two procedures. The main purpose of the study is to determine whether modified mini-PCNL is not worse than standard PCNL in achieving stone-free status shortly after surgery. Stone-free status will be assessed by low-dose noncontrast CT within 72 hours after surgery. The study will also compare stone-free status at 3 months, complications, operation time, length of hospital stay, need for additional procedures, and quality of life.

Eligibility criteria

Qualifiers

Adults aged ≥18 years.

Serum creatinine ≤133 μmol/L.

American Society of Anesthesiologists (ASA) physical status classification I-III.

S.T.O.N.E. score ≥8.

Disqualifiers

Solitary kidney.

Morbid obesity (body mass index ≥35 kg/m²).

Previous renal transplantation or urinary diversion.

Congenital abnormalities of the urinary tract.

Trial design

Treatments tested in this trial

  • 20 Fr Modified Mini Percutaneous Nephrolithotomy
  • 24 Fr Standard Percutaneous Nephrolithotomy

Treatment groups

1,380 Participants
are divided into 2 treatment groups