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Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
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.
Official title: Modified Mini Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy for the Treatment of Complex Renal Calculi: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
1380
Start Date
2026-07-15
Completion Date
2027-09-14
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
20 Fr Modified Mini Percutaneous Nephrolithotomy
Modified mini percutaneous nephrolithotomy performed with a 20 Fr access sheath and F17 Hawk nephroscope. Stone fragmentation may be performed using pneumatic lithotripsy, Ho:YAG laser, or thulium fiber laser according to the standardized surgical protocol.
24 Fr Standard Percutaneous Nephrolithotomy
Standard percutaneous nephrolithotomy performed with a 24 Fr access sheath and F20.8 Wolf nephroscope. Stone fragmentation may be performed using pneumatic lithotripsy, Ho:YAG laser, or thulium fiber laser according to the standardized surgical protocol.
Locations (1)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China