Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-28 @ 9:14 AM
Study NCT ID:
NCT05565066
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Comparison of FNB and FNA in IHC-required Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D000081012', 'term': 'Autoimmune Pancreatitis'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-26', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-29', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yields of EUS-FNA with EUS-FNB for solid masses', 'timeFrame': 'From admission until the date of pathological diagnosis obtained or follow-up up to 24 months', 'description': 'Overall dignostic yields of all solid lesions'}, {'measure': 'Diagnostic yields of EUS-FNA with EUS-FNB for solid masses', 'timeFrame': 'From admission until the date of pathological diagnosis obtained or follow-up up to 24 months', 'description': 'dignostic yields of AIP'}, {'measure': 'Diagnostic yields of EUS-FNA with EUS-FNB for solid masses', 'timeFrame': 'From admission until the date of pathological diagnosis obtained or follow-up up to 24 months', 'description': 'dignostic yields of NET'}, {'measure': 'Diagnostic yields of EUS-FNA with EUS-FNB for solid masses', 'timeFrame': 'From admission until the date of pathological diagnosis obtained or follow-up up to 24 months', 'description': 'dignostic yields of GIST'}], 'secondaryOutcomes': [{'measure': 'Quality of histologic specimen', 'timeFrame': 'From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks', 'description': 'Specimen adequacy - whether adequate for IHC staining'}, {'measure': 'Quality of histologic specimen', 'timeFrame': 'From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks', 'description': 'Specimen adequacy - tissue intergrity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic ultrasound', 'Pathological diagnosis', 'Fine needle aspiration', 'Fine needle biopsy'], 'conditions': ['Neuroendocrine Tumors', 'Autoimmune Pancreatitis', 'Gastrointestinal Stromal Tumors']}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. The investigators conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with lesions requiring immunohistochemistry (IHC) pathological diagnosis.', 'detailedDescription': "Current guidelines recommend FNA and FNB needles equally for pancreatic and other deep-seated lesions. However, some studies indicate that the sample adequacy for histologic evaluation is higher when using FNB compared with FNA needles. The diagnosis of neuroendocrine tumor (NET), autoimmune pancreatitis (AIP), and other gastrointestinal stromal tumors require high-quality tissue sampling for IHC diagnosis. Whether FNB is superior to FNA in these IHC-required lesions remains unclear.\n\nThe investigators performed this at 2 tertiary care centers in China. The study prospectively collected patients undergoing EUS for a solid mass (\\>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity from December 2014 diagnosed with AIP, NET, mesenchymal tumors, and Lymphoma. Patients accepted FNB or FNA according to doctors' and patients' willingness in a real-world setting. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as AIP, NET, mesenchymal tumors, and lymphoma. The secondary endpoint was the quality of the histologic specimen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years;\n* presence of a solid mass lesion was confirmed by at least 1 imaging modality and it was located within pancreas, abdomen, mediastinum, or pelvic cavity;\n* mass size \\>1 cm;\n* final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion, including AIP, NET, mesenchymal tumors, and lymphoma.\n\nExclusion Criteria:\n\n* coagulopathy (international normalized ratio, 1.5);\n* thrombocytopenia (platelet count \\<50,000/mm3);\n* acute pancreatitis within the previous 2 weeks;\n* inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction);\n* refusal or inability to provide an informed consent.'}, 'identificationModule': {'nctId': 'NCT05565066', 'briefTitle': 'A Real-world Comparison of FNB and FNA in IHC-required Lesions.', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A Real-world Comparison of FNB and FNA in IHC-required Lesions: A Prospective, Multicenter Study.', 'orgStudyIdInfo': {'id': 'FNB-2022tj'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FNB group', 'description': "FNB needles adpted to acquire lesion tissues according patients' advice and patients' willings.", 'interventionNames': ['Device: FNB group']}, {'label': 'FNA group', 'description': "FNA needles adpted to acquire lesion tissues according patients' advice and patients' willings.", 'interventionNames': ['Device: FNA group']}], 'interventions': [{'name': 'FNB group', 'type': 'DEVICE', 'description': 'Fine-needle-biopsy (Echotip ProCore Needle)', 'armGroupLabels': ['FNB group']}, {'name': 'FNA group', 'type': 'DEVICE', 'description': 'Fine-needle-aspiration (Echotip Needle)', 'armGroupLabels': ['FNA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Bin Cheng', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}