Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT04606758
Status:
UNKNOWN
Last Update Posted:
2020-10-28
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014514', 'term': 'Ureteral Calculi'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss as estimated by postoperative decreases in haemoglobin', 'timeFrame': 'Post-operative day 1'}], 'secondaryOutcomes': [{'measure': 'Surgical outcomes', 'timeFrame': '6 months', 'description': 'Outcome measures by using the clavien dindo classification system'}, {'measure': 'Asses the easiness of accessibility of the targeted stone', 'timeFrame': 'Intraoperatively', 'description': 'Outcome measures by counting numbers of puncture trial'}, {'measure': 'The Puncture fluoroscopy screening time', 'timeFrame': 'Intraoperatively', 'description': 'assessed on the monitor of C-Arm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urolithiasis', 'Kidney Stone', 'Kidney Diseases', 'Ureteral Calculi', 'Kidney Calculi']}, 'descriptionModule': {'briefSummary': 'Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.', 'detailedDescription': 'This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for PCNL at participating institution\n* Patients of all ethnic backgrounds\n* Stone size over 10 mm in diameter and a density over 900 Hounsfield units\n* Patients with a large calculus in the upper third of the ureter\n\nExclusion Criteria:\n\n* Pregnancy\n* infectious disease of the genitals;\n* conditions that violate the configuration of the kidneys (curvature of the spinal column)\n* anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)\n* presence of nephrostomy drainage in the target kidney;\n* urethral stricture or other reason leading to the inability to carry out ureteral catheterization;\n* other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;\n* patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;\n* patients with a history of mental illness;\n* participation in another research that interferes with this research;\n* acute renal failure;\n* dissecting aortic aneurysm;\n* acute hypertensive encephalopathy;\n* heavy arterial bleeding;\n* myocardial infarction less than six months before enrollment in the study;\n* Stroke less than six months before enrollment in the study;\n* Insufficiency of blood circulation III-IV New York Heart Association class;\n* Severe rhythm and conduction disturbances;\n* Increase in the level of liver transaminases by more than three times;'}, 'identificationModule': {'nctId': 'NCT04606758', 'briefTitle': 'Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease', 'organization': {'class': 'OTHER', 'fullName': 'Astana Medical University'}, 'officialTitle': 'Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones', 'orgStudyIdInfo': {'id': '8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCNL under fluoroscopic control', 'interventionNames': ['Procedure: PCNL under fluoroscopic control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCNL under ultrasound control', 'interventionNames': ['Procedure: PCNL under ultrasound control']}], 'interventions': [{'name': 'PCNL under fluoroscopic control', 'type': 'PROCEDURE', 'description': 'Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance', 'armGroupLabels': ['PCNL under fluoroscopic control']}, {'name': 'PCNL under ultrasound control', 'type': 'PROCEDURE', 'description': 'Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance', 'armGroupLabels': ['PCNL under ultrasound control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ulanbek Zhanbyrbekuly', 'role': 'CONTACT', 'email': 'ulanbek.amu@gmail.com', 'phone': '+77071652019'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astana Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medipol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}