Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT07295860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FANS-FURS vs Suction Mini-PCNL for 2-3 cm Renal Stones: A Multicenter Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and surgeons are unblinded due to the nature of surgical interventions. However, postoperative imaging and clinical outcome assessment will be performed by blinded independent assessors."'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 254}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone-free rate (SFR) at 1 month postoperatively', 'timeFrame': '1 month postoperatively', 'description': '. SFR will be evaluated using a spiral non-contrast computed tomography (NCCT) scan performed at 1 month after the procedure. Stone-free status will be categorized as no residual or with residual fragments'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal stones Kidney calculi Nephrolithiasis Urolithiasis RIRS FURS FANS Suction mini-PCNL Stone-free rate Endourology'], 'conditions': ['Renal Stones']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, randomized clinical trial compares FANS-assisted flexible ureteroscopy (FURS) with suction-assisted mini-percutaneous nephrolithotomy (mini-PCNL) for the treatment of renal stones measuring 2-3 cm. A total of 280 patients will be enrolled across nine tertiary centers and randomized 1:1 to either technique. The primary endpoint is stone-free rate (SFR) at 1 month, assessed by non-contrast CT. Secondary outcomes include operative time, intraoperative complications, postoperative morbidity (Clavien-Dindo), pain scores, hospital stay, reinterventions, and quality of life (EQ-5D-5L). The study aims to provide the first high-quality head-to-head evidence comparing these two modern suction-enhanced technologies, with the goal of defining the optimal minimally invasive approach for medium-sized renal stones.', 'detailedDescription': "Aim of the Study\n\nThe primary aim of this study is to compare the stone-free rate (SFR) of FANS-assisted flexible ureteroscopy versus suction-assisted mini-percutaneous nephrolithotomy (mini-PCNL) in patients with renal stones measuring 2 to 3 cm. Secondary aims include comparing perioperative outcomes, complication rates, length of hospital stay, and patient-reported quality of life between the two treatment modalities.\n\nPatients and Methods Study Design\n\nThis is a prospective, multicenter, randomized, superiority trial. Patients will be recruited from nine high-volume tertiary referral centers. Participants will be randomized in a 1:1ratio to undergo either FANS-based flexible ureteroscopy or suction mini-PCNL using a computer-generated randomization tables, stratified by each center. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE) prepared by an independent person who is not involved in patients' recruitment or treatment. Surgeons and investigators will be blinded to group allocation until the point of intervention.\n\nEthical Considerations The study protocol will be approved by the Institutional Review Board (IRB) of each participating center. All patients will provide written informed consent before enrollment. The study will be conducted in accordance with the principles of the Declaration of Helsinki.\n\nPatient Evaluation and Recruitment All patients will undergo a standardized preoperative assessment including medical history, physical examination, blood tests (CBC, renal function, coagulation profile), urinalysis, urine culture, and non-contrast CT (NCCT) for stone size, density (HU), and volume assessment. Eligible patients will be screened and enrolled after providing informed consent. Antibiotic prophylaxis will be administered according to European Association of Urology (EAU) guidelines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years old.\n* Single or multiple renal stones measuring 2 -3 cm (diagnosed by NCCT).\n* Negative urine culture prior to surgery.\n* Suitable for general/spinal anesthesia.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Active urinary tract infection.\n* Anomalous renal anatomy (e.g., horseshoe kidney).\n* Severe ureteral strictures preventing retrograde access.\n* Coagulopathy or inability to discontinue anticoagulation.'}, 'identificationModule': {'nctId': 'NCT07295860', 'acronym': 'NILE Stone Stu', 'briefTitle': 'FANS-FURS vs Suction Mini-PCNL for 2-3 cm Renal Stones: A Multicenter Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'A Multicenter Randomized Trial Comparing FANS-Based Flexible Ureteroscopy Versus Suction Mini-Percutaneous Nephrolithotomy for Renal Stones 2-3 cm. The National Innovative Large Egyptian (NILE) Stone Study.', 'orgStudyIdInfo': {'id': 'NILE Stone Study'}, 'secondaryIdInfos': [{'id': 'RP.25.8.1033', 'type': 'OTHER', 'domain': 'Faculty of medicine, Mansoura University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FANS-Based Flexible Ureteroscopy (FURS)', 'interventionNames': ['Procedure: FANS-Based Flexible Ureteroscopy (FURS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suction-Assisted Mini-PCNL', 'interventionNames': ['Procedure: Suction-Assisted Mini-PCNL']}], 'interventions': [{'name': 'FANS-Based Flexible Ureteroscopy (FURS)', 'type': 'PROCEDURE', 'description': 'Under general/ spinal anesthesia, patients will be placed in lithotomy position. After guidewire placement, a flexible navigable suction ureteral access sheath (FANS) will be advanced to the renal pelvis. Lithotripsy will be performed using a digital flexible ureteroscope and holmium laser with optimized settings for dusting and fragmentation. Continuous irrigation combined with active suction will enhance visualization and fragment clearance. A double-J stent will be placed post-procedure.', 'armGroupLabels': ['FANS-Based Flexible Ureteroscopy (FURS)']}, {'name': 'Suction-Assisted Mini-PCNL', 'type': 'PROCEDURE', 'description': "Under general or spinal anesthesia, patients will be placed in the prone position. Percutaneous renal access will be achieved under ultrasound or fluoroscopy guidance using an 18G puncture needle. Tract dilation will be performed up to 16-22 Fr, followed by the insertion of a suction-enabled miniaturized sheath (e.g., ClearPetra or equivalent). A mini-nephroscope will be introduced to visualize and fragment stones using Holmium:YAG fiber laser. Continuous irrigation combined with active negative-pressure suction through the access sheath will facilitate real-time removal of stone dust and fragments while maintaining low intrarenal pressure and clear visualization. A nephrostomy tube or double-J stent will be inserted at the surgeon's discretion.", 'armGroupLabels': ['Suction-Assisted Mini-PCNL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Outside U.S./Canada', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud AN Laymon', 'role': 'CONTACT', 'email': 'dr_mahmoudlaymon@mans.edu.eg', 'phone': '066053151'}], 'facility': 'Urology and nephrology center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mahmoud AN Laymon, A.Prof.', 'role': 'CONTACT', 'email': 'dr_mahmoudlaymon@mans.edu.eg', 'phone': '066053151'}, {'name': 'Ahmed Shokeir, Prof', 'role': 'CONTACT', 'email': 'ahmed.shokeir@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}