Modified Mini-PCNL Versus Standard PCNL for Complex Kidney Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 20 Fr Modified Mini Percutaneous Nephrolithotomy, 24 Fr Standard Percutaneous Nephrolithotomy.
- Who it may be relevant to
- Registry conditions: Kidney Stones, Complex Renal Calculi. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Modified Mini Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy for the Treatment of Complex Renal Calculi: A Multicenter Randomized Controlled Trial
Overview
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.
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.
Primary outcome measures
- Immediate Stone-Free Rate [Time frame: Within 72 hours after surgery]
Secondary outcome measures (2)
- Stone-Free Rate at 3 Months [Time frame: 3 months after surgery]
- Length of Hospital Stay [Time frame: From surgery to hospital discharge, assessed up to 30 days after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
Publications
- Zeng G, Cai C, Duan X, Xu X, Mao H, Li X, Nie Y, Xie J, Li J, Lu J, Zou X, Mo J, Li C, Li J, Wang W, Yu Y, Fei X, Gu X, Chen J, Kong X, Pang J, Zhu W, Zhao Z, Wu W, Sun H, Liu Y, la Rosette J. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. 2021 Jan PMID 32994063
Identifiers
NCT: NCT07697677 · ES-2025-285-02 · GMUCR2025-01006