Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 12:24 PM
Study NCT ID:
NCT07352267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration in the Diagnosis of Lymphoma: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-11', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '7 days after sampling'}], 'secondaryOutcomes': [{'measure': 'Diagnostic sensitivity', 'timeFrame': '7 days after smpling'}, {'measure': 'Incidence of complications', 'timeFrame': '7 days after sampling'}, {'measure': 'Rate of specimen adequacy', 'timeFrame': '7 days after sampling'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endobronchial ultrasound', 'Transbronchial needle aspiration', 'Transbronchial mediastinal cryobiopsy', 'Lymphoma'], 'conditions': ['Mediastinal and Hilar Lymphadenopathy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn which of two minimally invasive procedures is better at safely diagnosing lymphoma in the mediastinum (chest) in adults (aged 18 and older) who are suspected to have either a new or a returning (relapsed) lymphoma. The main questions it aims to answer are:\n\nWhich procedure, endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), has a higher success rate in obtaining a definitive diagnosis? Is one procedure safer than the other in terms of complications? Researchers will compare the EBUS-TBMC group to the EBUS-TBNA group to see if the cryobiopsy technique leads to better diagnostic results and has a similar or better safety profile.\n\nParticipants will:\n\nBe randomly assigned to undergo one of the two diagnostic procedures (EBUS-TBMC or EBUS-TBNA) during a single bronchoscopy session.\n\nHave their tissue samples analyzed by pathologists. Be followed clinically for at least 6 months to confirm the final diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Presence of mediastinal lymphadenopathy of unknown etiology.\n* Clinical suspicion of lymphoma, based on any of the following:\n\nPrevious history of lymphoma (suspected relapse). Presence of lymphoma at another site. Clinical and radiographic findings suggestive of new isolated mediastinal lymphoma (e.g., isolated idiopathic bulky mediastinal adenopathy with or without systemic symptoms), as assessed by the study bronchoscopists.\n\nExclusion Criteria:\n\n* A more probable alternative cause for lymphadenopathy is identified (e.g., lung cancer or other non-lymphoproliferative malignancies).'}, 'identificationModule': {'nctId': 'NCT07352267', 'briefTitle': 'Diagnostic Value and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration in the Diagnosis of Lymphoma: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Diagnostic Value and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration in the Diagnosis of Lymphoma: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DETECTION-LYM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endobronchial ultrasound-guided transbronchial needle aspiration', 'interventionNames': ['Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration']}, {'type': 'EXPERIMENTAL', 'label': 'Endobronchial ultasound-guided transbronchial mediastinal cryobiopsy', 'interventionNames': ['Procedure: Endobronchial ultrasound-guided tranbronchial mediastinal cryobiopsy']}], 'interventions': [{'name': 'Endobronchial ultrasound-guided transbronchial needle aspiration', 'type': 'PROCEDURE', 'description': 'After the target lymph nodes are determined and the safety of needle aspiration is ensured, a 19-G needle will be placed in the working channel of the EBUS scope. The tip of the sheath of the needle will be visible on the endobronchial view, and the needle will then be allowed to pierce the airway wall and enter the lymph node using the jabbing technique under direct ultrasound guidance. A 50-mL syringe will be used to collect 20 mL of aspirates, which will be maintained for 20 s. Each lymph node will be sampled five times to optimize the diagnostic yield. Five passes per node are planned. The samples will not be evaluated on site.', 'armGroupLabels': ['Endobronchial ultrasound-guided transbronchial needle aspiration']}, {'name': 'Endobronchial ultrasound-guided tranbronchial mediastinal cryobiopsy', 'type': 'PROCEDURE', 'description': 'After the target lymph node is located (vascular structures will be excluded via the Doppler function), a tunnel will be made between the target lymph node and the airway wall using a 19-G needle. Subsequently, a 1.1-mm cryoprobe (Erbe 20 402-401, ERBE, Tübingen, Germany) will be inserted through the tunnel and positioned within the target lymph node under EBUS monitoring. The distance between the cryoprobe tip and the lymph node edge will be confirmed to be \\>5 mm in all four directions. Afterward, the probe will be cooled in liquid carbon dioxide for 5-9 s. A total of three passes will be performed.', 'armGroupLabels': ['Endobronchial ultasound-guided transbronchial mediastinal cryobiopsy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gang Hou', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}