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| ID | Type | Description | Link |
|---|---|---|---|
| ES-2025-252-02 | Other Identifier | The First Affiliated Hospital of Guangzhou Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FANS-assisted mini-PCNL | Experimental | Mini-percutaneous nephrolithotomy performed using a flexible mini-nephroscope combined with a flexible and navigable suction access sheath to facilitate flexible access and active stone fragment evacuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FANS-assisted mini-percutaneous nephrolithotomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate stone-free rate | Absence of residual stones or fragments >2 mm detected by non-contrast CT | Postoperative day 0 to 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate at 1 month | Absence of residual stones or fragments >2 mm detected by non-contrast CT | Postoperative day 30 (±7 days) |
| Operative time | Total duration of the surgical procedure measured from puncture to completion of the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510230 | China |
Individual participant data will not be shared, as this is a single-center prospective pilot study with a small sample size, and the data will be used primarily for exploratory and hypothesis-generating purposes.
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| From skin puncture to completion of the procedure (intraoperative period) |
| Postoperative pain score | 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 day 1 |
| Postoperative complications | Incidence and severity of postoperative complications classified according to the Clavien-Dindo grading system | Postoperative day 0 to 30 |
| Length of postoperative hospital stay | Duration of hospital stay measured from completion of the procedure to hospital discharge | Postoperative day 0 to postoperative day 14 |
| Quality of life score | 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. | Baseline and postoperative day 30 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |