Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Kidney Stones
NCT ID: NCT07159035
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
640 participants
INTERVENTIONAL
2025-08-28
2026-03-31
Brief Summary
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A total of 640 eligible adult patients will be enrolled across 20 high-volume urology centers in China, Russia, Turkey, and India. Participants will be randomly assigned to undergo either FANS-assisted flexible ureteroscopy or mini-PCNL. The primary outcome is the immediate stone-free rate (SFR) assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include SFR at 1 month, operative time, pain score, length of hospital stay, complication rates, and changes in health-related quality of life.
The goal of this trial is to determine whether the less invasive FANS-assisted approach is non-inferior to mini-PCNL in terms of efficacy, while potentially offering advantages in postoperative recovery and safety.
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Detailed Description
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This trial will enroll 640 patients from 20 urology centers with substantial experience in endoscopic stone surgery, including hospitals in China, Russia, Turkey, and India. Eligible participants will be randomly assigned in a 1:1 ratio to either the FANS-assisted flexible ureteroscopy group or the mini-PCNL group. All patients will undergo preoperative imaging, intraoperative standardization, and postoperative follow-up according to the study protocol.
The primary endpoint is the stone-free rate (SFR) within 72 hours postoperatively, evaluated by non-contrast-enhanced computed tomography (NCCT). Secondary endpoints include SFR at 1 month, operative time, length of hospital stay, postoperative pain (measured by VAS score), complication rates (graded by Clavien-Dindo classification), changes in renal function, and health-related quality of life (HRQoL).
The FANS, developed to improve irrigation control and active stone fragment suction during flexible ureteroscopy, may provide better visualization, reduce intrarenal pressure, and shorten operative time. By directly comparing FANS-assisted fURS with mini-PCNL, the trial seeks to determine whether a less invasive method can achieve comparable outcomes in terms of stone clearance and complication rates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FANS-fURS Group
Patients assigned to this group will undergo flexible ureteroscopy with FANS (Flexible endoscopy-Assisted Negative-pressure Suction Sheath). The FANS facilitates direct stone visualization, fragmentation, suction, and removal under controlled pressure conditions.
Flexible ureteroscopy with FANS
The FANS with negative-pressure suction, enhancing intrarenal pressure control and fragment evacuation during flexible ureteroscopy.
mini-PCNL Group
Patients in this group will receive mini-percutaneous nephrolithotomy (mini-PCNL) via less than 20 Fr percutaneous tracts.
Mini-percutaneous nephrolithotomy (mini-PCNL)
Mini-PCNL is performed under general anesthesia with less than 20 Fr access tract, using rigid nephroscopy and stone fragmentation under direct visualization. Postoperative drainage is provided via nephrostomy or ureteral stent as per protocol.
Interventions
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Flexible ureteroscopy with FANS
The FANS with negative-pressure suction, enhancing intrarenal pressure control and fragment evacuation during flexible ureteroscopy.
Mini-percutaneous nephrolithotomy (mini-PCNL)
Mini-PCNL is performed under general anesthesia with less than 20 Fr access tract, using rigid nephroscopy and stone fragmentation under direct visualization. Postoperative drainage is provided via nephrostomy or ureteral stent as per protocol.
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiology (ASA) score 1-3;
3. Lower pole renal stones-single or multiple-with a maximal diameter of 1-2 cm confirmed by CT;
4. Ability to provide written informed consent and adhere to trial requirements.
Exclusion Criteria
2. Stones located within a calyceal diverticulum;
3. History of open nephrolithotomy or ureterolithomy (due to resultant intrarenal anatomical distortion);
4. Absolute contraindications to either FANS-f-URS or mini-PCNL, including:
* Uncorrectable coagulopathy;
* Active, uncontrolled urinary tract infection;
* Severe cardiopulmonary disease precluding safe general anesthesia (e.g. decompensated heart failure, refractory COPD);
* Pregnancy;
* Inability to tolerate lithotomy or prone positioning;
5. Inability to understand or complete trial documentation.
18 Years
75 Years
ALL
No
Sponsors
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Shengjing Hospital
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Saint Petersburg State University Hospital
UNKNOWN
Fortune Urology Clinic
UNKNOWN
Zhongda Hospital
OTHER
Tongji Hospital
OTHER
The First Affiliated Hospital Hengyang Medical School
UNKNOWN
First Affiliated Hospital of Ningbo University
NETWORK
The Sixth Affiliated Hospital of Guangzhou Medical University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Dehong People's Hospital
UNKNOWN
People's Hospital of Nanhai District, Foshan
UNKNOWN
Huadu District People's Hospital of Guangzhou
OTHER
Jiangmen Central Hospital
OTHER
Baoshan No.2 People's Hospital
UNKNOWN
Guizhou Provincial People's Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Tianjin Medical University Second Hospital
OTHER
Ankara University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Guohua Zeng
Vice-president
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Skolarikos A, Geraghty R, Somani B, Tailly T, Jung H, Neisius A, Petrik A, Kamphuis GM, Davis N, Bezuidenhout C, Lardas M, Gambaro G, Sayer JA, Lombardo R, Tzelves L. European Association of Urology Guidelines on the Diagnosis and Treatment of Urolithiasis. Eur Urol. 2025 Jul;88(1):64-75. doi: 10.1016/j.eururo.2025.03.011. Epub 2025 Apr 22.
Other Identifiers
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ES-2025-181
Identifier Type: -
Identifier Source: org_study_id
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