Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-25 @ 2:57 PM
Study NCT ID:
NCT01394159
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
22G FNA Needle vs. 22G ProCore Needle
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'svaradarajulu@yahoo.com', 'phone': '407-303-2570', 'title': 'Dr Shyam Varadarajulu', 'organization': 'Center for Interventional Endoscopy, Florida Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '22G ProCore Biopsy', 'description': 'Acquire biopsy with procore needle\n\nProcore Biopsy: Acquire tissue with procore biopsy needle', 'otherNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '22G FNA Needle', 'description': 'Acquire tissue with 22 gauge fine needle aspiration needle', 'otherNumAtRisk': 28, 'otherNumAffected': 1, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'abdominal pain', 'notes': 'This patient was in the FNA group and was managed conservatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild acute pancreatitis', 'notes': 'This patient was managed conservatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare the Median Number of Passes Required to Establish a Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '22G ProCore Biopsy', 'description': 'Acquire biopsy with procore needle\n\nProcore Biopsy: Acquire tissue with procore biopsy needle'}, {'id': 'OG001', 'title': '22G FNA Needle', 'description': 'Acquire tissue with 22 gauge fine needle aspiration needle'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'No. of passes for diagnosis', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnosis Achieved With the Needle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '22G ProCore Biopsy', 'description': 'Acquire biopsy with procore needle\n\nProcore Biopsy: Acquire tissue with procore biopsy needle'}, {'id': 'OG001', 'title': '22G FNA Needle', 'description': 'Acquire tissue with 22 gauge fine needle aspiration needle'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Technical Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '22G ProCore Biopsy', 'description': 'Acquire biopsy with procore needle\n\nProcore Biopsy: Acquire tissue with procore biopsy needle'}, {'id': 'OG001', 'title': '22G FNA Needle', 'description': 'Acquire tissue with 22 gauge fine needle aspiration needle'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '22G ProCore Biopsy', 'description': 'Acquire biopsy with procore needle\n\nProcore Biopsy: Acquire tissue with procore biopsy needle'}, {'id': 'FG001', 'title': '22G FNA Needle', 'description': 'Acquire tissue with 22 gauge fine needle aspiration needle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ProCore Biopsy', 'description': 'Acquire biopsy with procore needle\n\nProcore Biopsy: Acquire tissue with procore biopsy needle'}, {'id': 'BG001', 'title': 'FNA Needle', 'description': 'FNA: Acquire tissue with FNA needle'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-09', 'studyFirstSubmitDate': '2011-07-12', 'resultsFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-30', 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the Median Number of Passes Required to Establish a Diagnosis', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Diagnosis Achieved With the Needle', 'timeFrame': '6 months'}, {'measure': 'Technical Failure', 'timeFrame': '6 months', 'description': 'Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['passes required to establish diagnosis'], 'conditions': ['Pancreatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '22658389', 'type': 'DERIVED', 'citation': 'Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.', 'detailedDescription': 'In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-All patients with solid pancreatic mass lesions\n\nExclusion Criteria:\n\n* Coaguloapthy,\n* minors,\n* prgenant patients'}, 'identificationModule': {'nctId': 'NCT01394159', 'briefTitle': '22G FNA Needle vs. 22G ProCore Needle', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions', 'orgStudyIdInfo': {'id': 'F110506010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '22G ProCore biopsy needle', 'description': 'Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.', 'interventionNames': ['Procedure: 22G ProCore biopsy needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': '22G standard FNA needle', 'description': 'Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle.', 'interventionNames': ['Procedure: 22G standard FNA needle']}], 'interventions': [{'name': '22G ProCore biopsy needle', 'type': 'PROCEDURE', 'otherNames': ['Biopsy'], 'description': 'Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.', 'armGroupLabels': ['22G ProCore biopsy needle']}, {'name': '22G standard FNA needle', 'type': 'PROCEDURE', 'otherNames': ['biopsy'], 'description': 'Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.', 'armGroupLabels': ['22G standard FNA needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Shyam Varadarajulu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}