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RECRUITING
NCT07697677
NA

Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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