Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-03 @ 8:15 AM
Study NCT ID:
NCT02910960
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-15', 'releaseDate': '2022-02-16'}], 'estimatedResultsFirstSubmitDate': '2022-02-16'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total area of procured tissue between the two FNB needles', 'timeFrame': '48 hours', 'description': 'The primary objective of this study is to compare the total area of procured tissue between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses.\n\nPancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield a tissue volume greater than the SharkCore Fine Needle Biopsy System needle because the serrated design of the FNB needle tip is expected to procure greater volume of tissue. This will be measured using a specialized digital image analysis software.\n\nThis hypothesis will be tested by comparing the total tissue volume, tumor volume within the tissue, stroma volume within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. When evaluated together, the above measurement provide the total area of tissue procured.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic adequacy between the two FNB needles', 'timeFrame': '48 hours', 'description': 'The secondary objective of this study is to compare the diagnostic adequacy between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses.\n\nPancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield diagnostic adequacy with fewer passes as they are expected to procure a greater area tissue than the SharkCore Fine Needle Biopsy System needle.\n\nThis hypothesis will be tested by comparing the number of passes required to establish a onsite diagnosis using both needle types in individual patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fine needle biopsy', 'EUS', 'solid pancreatic mass'], 'conditions': ['Pancreatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '22248600', 'type': 'BACKGROUND', 'citation': 'Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.'}, {'pmid': '15100946', 'type': 'BACKGROUND', 'citation': 'Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.'}, {'pmid': '26561917', 'type': 'BACKGROUND', 'citation': 'Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12.'}, {'pmid': '20620274', 'type': 'RESULT', 'citation': 'Ngamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072.'}, {'pmid': '22341257', 'type': 'RESULT', 'citation': 'Othman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16.'}, {'pmid': '29305893', 'type': 'DERIVED', 'citation': 'Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device.', 'detailedDescription': 'At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using one of the two FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented.\n\nFour dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing.\n\nIf the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo EUS\n* Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction\n* Able and willing to provide written or verbal consent\n\nExclusion Criteria:\n\n* Unable to safely undergo EUS for any reason\n* Coagulopathy (Prothrombin time \\> 18 secs, platelet count \\< 80,000/ml)\n* Active alcohol or other drug use or significant psychiatric illness\n* Pregnancy\n* Unable or unwilling to provide consent'}, 'identificationModule': {'nctId': 'NCT02910960', 'acronym': 'Expect', 'briefTitle': 'Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Randomized Trial Comparing Two Fine Needle Biopsy Needles for Endoscopic Ultrasound-guided Sampling of Solid Pancreatic Masses.', 'orgStudyIdInfo': {'id': '886967'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acquire EUS Biopsy Device', 'description': 'All patients will undergo sampling of pancreatic masses using the Acquire EUS Biopsy Device. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.', 'interventionNames': ['Device: Acquire EUS Biopsy Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SharkCore Biopsy System', 'description': 'All patients will undergo sampling of pancreatic masses using the SharkCore Biopsy System. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.', 'interventionNames': ['Device: SharkCore Biopsy System']}], 'interventions': [{'name': 'Acquire EUS Biopsy Device', 'type': 'DEVICE', 'description': 'At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.', 'armGroupLabels': ['Acquire EUS Biopsy Device']}, {'name': 'SharkCore Biopsy System', 'type': 'DEVICE', 'description': 'At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.', 'armGroupLabels': ['SharkCore Biopsy System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Interventional Endoscopy - Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Shyam Varadarajulu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-02-16', 'type': 'RELEASE'}, {'date': '2022-03-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'AdventHealth'}}}}