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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
20 Fr Modified Mini Percutaneous Nephrolithotomy
Procedure/SurgeryModified 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
Procedure/SurgeryStandard 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.
Treatment groups
1,380 Participants
are divided into 2 treatment groupsGroup A: Modified Mini-PCNLExperimental treatment 1 intervention
Group B: Standard PCNLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Immediate Stone-Free Rate
Proportion of participants who achieve stone-free status after surgery. Stone-free status is defined as no residual stone visualized under endoscopy and no residual stone fragments, or residual fragments ≤2 mm, on low-dose noncontrast CT with 2-mm slice thickness.
Time frame
Within 72 hours after surgerySecondary outcomes
1
Stone-Free Rate at 3 Months
Proportion of participants who achieve stone-free status at 3-month follow-up according to low-dose noncontrast CT.
Time frame
3 months after surgery2
Length of Hospital Stay
Number of days from the day of surgery to the day of hospital discharge, rounded to the nearest whole day.
Time frame
From surgery to hospital discharge, assessed up to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov