Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT03766659
Status:
UNKNOWN
Last Update Posted:
2023-02-13
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EUS-FNB With MOSE vs EUS-FNA With ROSE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'International multicenter prospective randomized comparative study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '1 month after Procedure', 'description': 'the proportion of patients with adequate tissue for diagnosis'}], 'secondaryOutcomes': [{'measure': 'morbidity rate', 'timeFrame': '1 month after Procedure', 'description': 'Procedure-related morbidity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources.\n\nIn order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.', 'detailedDescription': 'The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 80 years\n* Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter\n\nExclusion Criteria:\n\n* Coagulopathy\n* Altered anatomy\n* Contraindications for conscious sedation\n* Pregnancy\n* Those who cannot provide informed consent'}, 'identificationModule': {'nctId': 'NCT03766659', 'acronym': 'MORE', 'briefTitle': 'EUS-FNB With MOSE vs EUS-FNA With ROSE', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)', 'orgStudyIdInfo': {'id': 'MORE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MOSE', 'description': 'EUS-FNB with MOSE', 'interventionNames': ['Diagnostic Test: MOSE']}, {'type': 'OTHER', 'label': 'ROSE', 'description': 'EUS-FNA with ROSE', 'interventionNames': ['Diagnostic Test: ROSE']}], 'interventions': [{'name': 'MOSE', 'type': 'DIAGNOSTIC_TEST', 'description': 'EUS-FNB with MOSE', 'armGroupLabels': ['MOSE']}, {'name': 'ROSE', 'type': 'DIAGNOSTIC_TEST', 'description': 'EUS-FNA with ROSE', 'armGroupLabels': ['ROSE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Charing C Chong, MBChB', 'role': 'CONTACT', 'email': 'Chongcn@surgery.cuhk.edu.hk', 'phone': '852-26321496'}, {'name': 'Charing C Chong, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Surgery; The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Charing CHONG', 'role': 'CONTACT', 'email': 'chongcn@surgery.cuhk.edu.hk', 'phone': '3505 3933'}, {'name': 'Philip Yeung', 'role': 'CONTACT', 'email': 'philipyeung@surgery.cuhk.edu.hk', 'phone': '3404 3933'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Charing Chong, MD', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}