FANS-Assisted Mini-PCNL for Complex Renal Stones
Mini-percutaneous Nephrolithotomy With a Flexible Mini-nephroscope and a Flexible and Navigable Suction Access Sheath for Complex Renal Stones: A Prospective Pilot Study
The First Affiliated Hospital of Guangzhou Medical University
30 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones. Thirty consecutive patients with renal stones ≥2 cm will be prospectively enrolled. All patients will undergo FANS-assisted mini-PCNL. The primary outcome is the immediate stone-free rate assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include operative parameters, postoperative pain, complications, length of hospital stay, and quality of life. This pilot study is designed to provide preliminary evidence supporting the feasibility and safety of FANS-assisted mini-PCNL and to inform the design of future larger-scale studies.
Eligibility
Inclusion Criteria5
- Adults aged 18 to 75 years
- Patients with renal stones measuring 2 cm or larger in maximum diameter
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Planned to undergo mini-percutaneous nephrolithotomy
- Able and willing to provide written informed consent
Exclusion Criteria4
- Uncontrolled urinary tract infection at the time of surgery
- Known bleeding tendency or coagulation disorders
- Contraindication to general anesthesia
- Pregnancy or breastfeeding
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Interventions
The procedure consists of mini-percutaneous nephrolithotomy (mini-PCNL) performed with the assistance of a flexible mini-nephroscope and a flexible and navigable suction access sheath (FANS). Following standard percutaneous renal access and initial stone fragmentation using a rigid nephroscope, a flexible mini-nephroscope is introduced through the percutaneous tract to access calyces that are difficult to reach with rigid instruments. Holmium:YAG laser lithotripsy is then performed under flexible endoscopic visualization. The flexible and navigable suction access sheath allows simultaneous irrigation and adjustable negative-pressure suction, enabling continuous evacuation of stone fragments during lithotripsy. Suction strength can be regulated intraoperatively to maintain a clear endoscopic field and facilitate controlled fragment removal. This procedure is applied to all participants in this prospective pilot study and aims to evaluate the feasibility and safety of flexible suction
Locations(1)
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NCT07332286