Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 1:04 AM
Study NCT ID:
NCT06913569
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072281', 'term': 'Lymphadenopathy'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-03-30', 'studyFirstSubmitQcDate': '2025-03-30', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'Six months after the procedure', 'description': 'The diagnostic yield is defined as the proportion of lymph nodes diagnosed by each biopsy to the total number of lymph nodes enrolled in the study.'}], 'secondaryOutcomes': [{'measure': 'Sample adequacy', 'timeFrame': 'Six months after the procedure', 'description': 'The adequacy rate of samples for genetic testing: measured as the percentage of lymph node samples qualified for next-generation sequencing among all malignant lymph nodes.'}, {'measure': 'Total procedure time', 'timeFrame': 'During the procedure', 'description': 'The total procedure time is defined as the time from the insertion of the bronchoscope to its removal.'}, {'measure': 'TTFB procedure time', 'timeFrame': 'During the procedure', 'description': 'The EBUS-TTFB procedure time is defined as the time from the insertion of the biopsy needle into the bronchoscope to the cessation of bleeding after the final TTFB.'}, {'measure': 'TBNA procedure time', 'timeFrame': 'During the procedure', 'description': 'The EBUS-TBNA procedure time is defined as the time from the insertion of the biopsy needle into the bronchoscope to the cessation of bleeding after the final TBNA.'}, {'measure': 'Tunnel creation success rate', 'timeFrame': 'During the procedure', 'description': 'Defined as the percentage of lymph nodes in the EBUS-TTFB group where successful tunneling was achieved among the total number of lymph nodes.'}, {'measure': 'Incidence of complications', 'timeFrame': 'Six months after the procedure', 'description': 'Including pneumothorax, infection, mediastinal hematoma, emphysema and etc.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphadenopathy']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy and safety of endobronchial ultrasound-guided transtunnel forceps biopsy to transbronchial needle aspiration in diagnosing inadequate lymph node specimens based on macroscopic on-site evaluation.', 'detailedDescription': 'Mediastinal and hilar lymphadenopathy are common clinical conditions. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the standard method recommended by guidelines for obtaining tissue from these patients. Endobronchial ultrasound-guided transbronchial forceps biopsy (EBUS-TBFB) can overcome the limitations of inadequate tissue acquisition with EBUS-TBNA, and its efficacy and safety have been proved. However, EBUS-TBFB often requires the assistance of the electrocautery for mediastinal window creation, which increases technical difficulty and requires electrosurgical equipment, making it unsuitable for application in grassroots hospitals.\n\nThis study aims to use the endobronchial ultrasound-guided transtunnel forceps biopsy (EBUS-TTFB) method. A single-use bronchoscopic puncture dilation catheter will be employed to establish a tunnel between the airway and the lymph node, with both puncture and dilation completed in the same procedure. Currently, there is a lack of prospective randomized controlled trials to verify the efficacy and safety of EBUS-TTFB.\n\nThis study is designed as a prospective, multicenter, randomized controlled trial. A total of 162 patients will be randomly allocated in a 1:1 ratio to the EBUS-TBNA group or the EBUS-TTFB group. The primary endpoint is thediagnostic yield. The secondary endpoints include specimen adequacy, procedure duration, tunnel creation success rate, and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Chest imaging shows mediastinal or hilar lymphadenopathy (short axis ≥10 mm), requiring EBUS-TBNA for definitive diagnosis;\n3. EBUS-TBNA can be performed on these lymph nodes, and the specimens obtained from conventional EBUS-TBNA with three needle passes are inadequate (macroscopic visible core \\< 30 mm);\n4. Willing to participate in this clinical study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Enlarged lymph nodes are identified as cystic or abscesses;\n2. Severe coagulopathy, insufficient anticoagulants/antiplatelets withdraw time or bleeding diathesis (platelets\\<50\\*109/L, INR\\>1.3) that do not meet bronchoscopy requirements;\n3. Other contraindications to bronchoscopy or transbronchial biopsy, such as severe cardiopulmonary insufficiency, intolerance to anesthesia, or endoscopic procedures;\n4. Patients who have participated in another clinical trial within the past three months;\n5. Vulnerable groups, such as pregnant women\n6. Any other condition that the investigator considers inappropriate for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06913569', 'briefTitle': 'EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Endobronchial Ultrasound-Guided Transtunnel Forceps Biopsy vs. Transbronchial Needle Aspiration for Diagnosing Inadequate Lymph Node Specimens Based on Macroscopic On-site Evaluation: A Prospective, Randomized, Multicenter Study', 'orgStudyIdInfo': {'id': 'SHCHE202502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EBUS-TBNA', 'description': 'Specimens were obtained using a 22-gauge biopsy needle by bronchoscope. Each lymph node was operated 4 passes.', 'interventionNames': ['Procedure: EBUS-TBNA']}, {'type': 'EXPERIMENTAL', 'label': 'EBUS-TTFB via a tunnel', 'description': 'A tunnel to reach the lymph node is established by making use of a puncture dilation catheter, and specimens were obtained using a 1.5 mm biopsy forceps by bronchoscope. Conduct biopsies until 5-10 specimens are obtained, and the actual number of passes and effective specimens should be recorded.', 'interventionNames': ['Procedure: EBUS-TTFB']}], 'interventions': [{'name': 'EBUS-TBNA', 'type': 'PROCEDURE', 'description': 'Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.', 'armGroupLabels': ['EBUS-TBNA']}, {'name': 'EBUS-TTFB', 'type': 'PROCEDURE', 'description': 'Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.', 'armGroupLabels': ['EBUS-TTFB via a tunnel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110032', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shitao Mao', 'role': 'CONTACT', 'email': 'mst2012@sina.cn', 'phone': '+86 18900916056'}], 'facility': 'The Fourth Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayuan Sun, PhD', 'role': 'CONTACT', 'email': 'jysun1976@163.com', 'phone': '+86-021-22200000', 'phoneExt': '1511'}], 'facility': 'Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '313000', 'city': 'Huizhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Te Zhang, B Med', 'role': 'CONTACT', 'email': '13857271121@163.com', 'phone': '+86 2555774'}], 'facility': 'Huzhou Central Hospital'}], 'centralContacts': [{'name': 'Jiayuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'xkyyjysun@163.com', 'phone': '+86-021-22200000', 'phoneExt': '1511'}], 'overallOfficials': [{'name': 'Jiayuan Sun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Respiratory Endoscopy', 'investigatorFullName': 'Jiayuan Sun', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}