Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-27 @ 11:59 PM
Study NCT ID:
NCT01936467
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
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': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'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': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkhasha1@jhmi.edu', 'phone': '443-287-1960', 'title': 'Dr. Mouen Khashab', 'organization': 'Johns Hopkins Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The endosonographers were not blinded to the procedure technique. A small possibility that cytotechnicians may have witnessed the technique. Cellularity of the specimens were not quantified. A 6 months follow-up may not detect all false negatives'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously', 'otherNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Yield of Capillary Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}], 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 months', 'description': 'Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.', 'unitOfMeasure': 'percentage of specimen', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Diagnostic Yield of Standard Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 months', 'description': 'Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.', 'unitOfMeasure': 'percentage of specimen', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sensitivity of EUS-FNA With Capillary Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Positive Gold Standard', 'description': 'gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.'}, {'id': 'OG001', 'title': 'Patients With Negative Gold Standard', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}], 'classes': [{'title': 'Positive EUS-FNA', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative EUS-FNA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'paramValue': '93.7', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Specificity', 'ciNumSides': 'TWO_SIDED', 'paramValue': '100', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Sensitivity of the EUS-FNA with Capillary technique', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.'}, {'type': 'PRIMARY', 'title': 'Sensitivity of EUS-FNA With StandardTechnique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Positive Gold Standard', 'description': 'gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.'}, {'id': 'OG001', 'title': 'Patients With Negative Gold Standard', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}], 'classes': [{'title': 'Positive EUS-FNA', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Negative EUS-FNA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Sensitivity', 'ciNumSides': 'TWO_SIDED', 'paramValue': '88.6', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Specificity', 'ciNumSides': 'TWO_SIDED', 'paramValue': '100', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Sensitivity of the EUS-FNA with Capillary technique', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.'}, {'type': 'PRIMARY', 'title': 'Sensitivity of EUS-FNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'id': 'OG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '93.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions', 'unitOfMeasure': 'percentage of positive gold standard', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.'}, {'type': 'SECONDARY', 'title': 'First Pass Diagnostic Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'id': 'OG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'immediate', 'description': 'The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acquisition of Core Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'id': 'OG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'immediate', 'description': 'The rate of acquiring core tissue of the pancreatic mass through EUS-FNA', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnostic Accuracy of EUS-FNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'id': 'OG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '93.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease', 'unitOfMeasure': 'percent accurate', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'id': 'FG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled between September 2013 and December 2014 in two tertiary academic centers', 'preAssignmentDetails': 'Patients were excluded from the study because a predominantly cystic lesion was found; the lack of an appreciable mass at EUS, unavailable on-site pathology and respiratory distress precluding completion of the examination'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Suction Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.\n\nStandard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'id': 'BG001', 'title': 'Capillary Technique', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.\n\nCapillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '64.15', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior History', 'classes': [{'title': 'Chronic Pancreatitis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Chemotherapy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Radiation therapy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior non-diagnostic FNA', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Antiplatelet therapy', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pancreatic mass Location', 'classes': [{'title': 'Uncinate/Head', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Neck', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Body', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Tail', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pancreatic mass size', 'classes': [{'categories': [{'measurements': [{'value': '2.86', 'spread': '1.23', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.63', 'groupId': 'BG001'}, {'value': '3.03', 'spread': '1.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Echogeicity of the lesion', 'classes': [{'title': 'Hypoecho', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': 'Isoecho', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Hyperecho', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cystic Component', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'mass'}, {'title': 'Vascular involvement', 'classes': [{'title': 'Arterial', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Venous', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Arterial and Venous', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'mass'}, {'title': 'EUS features of chronic pancreatitis', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Biliary stent present', 'classes': [{'title': 'Metal stent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Plastic stent', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients having biliary stent at the time of EUS-FNA', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2013-08-29', 'resultsFirstSubmitDate': '2016-08-20', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-02', 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Yield of Capillary Technique', 'timeFrame': 'up to 6 months', 'description': 'Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.'}, {'measure': 'Diagnostic Yield of Standard Technique', 'timeFrame': 'up to 6 months', 'description': 'Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.'}, {'measure': 'Sensitivity of EUS-FNA With Capillary Technique', 'timeFrame': '6 months', 'description': 'Sensitivity of the EUS-FNA with Capillary technique'}, {'measure': 'Sensitivity of EUS-FNA With StandardTechnique', 'timeFrame': '6 months', 'description': 'Sensitivity of the EUS-FNA with Capillary technique'}, {'measure': 'Sensitivity of EUS-FNA', 'timeFrame': '6 months', 'description': 'Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions'}], 'secondaryOutcomes': [{'measure': 'First Pass Diagnostic Rate', 'timeFrame': 'immediate', 'description': 'The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass'}, {'measure': 'Acquisition of Core Tissue', 'timeFrame': 'immediate', 'description': 'The rate of acquiring core tissue of the pancreatic mass through EUS-FNA'}, {'measure': 'Diagnostic Accuracy of EUS-FNA', 'timeFrame': '6 months', 'description': 'The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic solid lesions', 'Pancreatic mass', 'Pancreatic cancer', 'Endoscopic Ultrasound', 'EUS', 'Fine needle aspiration', 'FNA', 'EUS-FNA'], 'conditions': ['Pancreatic Solid Lesions', 'Pancreatic Mass']}, 'referencesModule': {'references': [{'pmid': '29272906', 'type': 'DERIVED', 'citation': 'Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.\n\nThere are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA\n\nExclusion Criteria:\n\n* Uncorrectable coagulopathy (INR \\> 1.5)\n* Uncorrectable thrombocytopenia (platelet \\< 50,000)\n* Uncooperative patients\n* Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)\n* Refusal to consent form\n* Cystic lesions\n* Inaccessible lesions to EUS'}, 'identificationModule': {'nctId': 'NCT01936467', 'briefTitle': 'Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided', 'orgStudyIdInfo': {'id': 'NA_00079301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard suction', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.', 'interventionNames': ['Device: Standard technique EUS-FNA']}, {'type': 'EXPERIMENTAL', 'label': 'Capillary suction', 'description': 'These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.', 'interventionNames': ['Device: Capillary suction technique for EUS FNA']}], 'interventions': [{'name': 'Standard technique EUS-FNA', 'type': 'DEVICE', 'description': 'Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.', 'armGroupLabels': ['Standard suction']}, {'name': 'Capillary suction technique for EUS FNA', 'type': 'DEVICE', 'description': 'Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously', 'armGroupLabels': ['Capillary suction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Howard County General Hospital', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}], 'overallOfficials': [{'name': 'Mouen A Khashab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Univeristy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Director of Therapeutic Endoscopy', 'investigatorFullName': 'Mouen Khashab', 'investigatorAffiliation': 'Johns Hopkins University'}}}}