Kidney Stones
Conditions
Keywords
PCNL, FANS, kidney stone, mini-PCNL
Brief 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.
Detailed description
Conventional mini-PCNL may be limited by restricted access to anatomically challenging calyces and inefficient evacuation of stone fragments when flexible nephroscopy is required. A novel technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) has been developed to enable flexible intrarenal navigation combined with active suction during antegrade lithotripsy. This prospective pilot study will enroll 30 consecutive patients undergoing FANS-assisted mini-PCNL for complex renal stones. The study focuses on feasibility, safety, and preliminary clinical outcomes, including stone clearance and perioperative morbidity. The results will serve as preliminary data for future confirmatory or comparative clinical trials.
Interventions
PROCEDUREFANS-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
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Uncontrolled urinary tract infection at the time of surgery * Known bleeding tendency or coagulation disorders * Contraindication to general anesthesia * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate stone-free rate | Postoperative day 0 to 3 | Absence of residual stones or fragments \>2 mm detected by non-contrast CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free rate at 1 month | Postoperative day 30 (±7 days) | Absence of residual stones or fragments \>2 mm detected by non-contrast CT |
| Operative time | From skin puncture to completion of the procedure (intraoperative period) | Total duration of the surgical procedure measured from puncture to completion of the operation |
| Postoperative pain score | Postoperative day 1 | Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Postoperative complications | Postoperative day 0 to 30 | Incidence and severity of postoperative complications classified according to the Clavien-Dindo grading system |
| Length of postoperative hospital stay | Postoperative day 0 to postoperative day 14 | Duration of hospital stay measured from completion of the procedure to hospital discharge |
| Quality of life score | Baseline and postoperative day 30 | Health-related quality of life assessed using the Wisconsin Stone Quality of Life (WISQOL) questionnaire, which consists of 28 items scored on a 5-point Likert scale. Total scores range from 0 to 140, with higher scores indicating better quality of life. |
Countries
China
Outcome results
None listed