FANS-Assisted Mini-PCNL for Complex Renal Stones

Condition(s) studied

Investigational drug(s) / intervention(s)

FANS-assisted mini-percutaneous nephrolithotomy: 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

Study 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

Primary outcome measure(s)

• Immediate stone-free rate — Postoperative day 0 to 3
  Absence of residual stones or fragments \>2 mm detected by non-contrast CT

Trial sites (1)

More The First Affiliated Hospital of Guangzhou Medical University trials in China

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