Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones
Recruiting now · Not applicable
Conditions studied: Kidney Stones, Complex Renal Calculi
In brief
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.
Key facts
- Study ID
- NCT07697677
- Run by
- The First Affiliated Hospital of Guangzhou Medical University
- People needed
- 1380
- Starts
- 2026-07-15
- Expected to finish
- 2027-09-14
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
- Patients who provide written informed consent and agree to undergo either modified mini-percutaneous nephrolithotomy or standard percutaneous nephrolithotomy.
You may not qualify if…
- Solitary kidney.
- Morbid obesity (body mass index ≥35 kg/m²).
- Previous renal transplantation or urinary diversion.
- Congenital abnormalities of the urinary tract.
- Pregnancy.
- Uncorrected coagulopathy.
- Active urinary tract infection.
Where it is running
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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