Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:07 AM
Study NCT ID:
NCT07419620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '7 days after the procedure', 'description': 'The proportion of cases with a specific diagnosis made based on the initial biopsy (UEPB or semi-rigid thoracoscopic pleural biopsy) specimens.'}], 'secondaryOutcomes': [{'measure': 'diagnostic sensitivity', 'timeFrame': '7 days after procedure', 'description': 'The proportion of participants with a final diagnosis of specific diseases who are correctly identified by the initial biopsy method.'}, {'measure': 'Diagnostic specificity', 'timeFrame': '7 days after procedure', 'description': 'The proportion of participants with a final malignant diagnosis who are correctly identified by the initial biopsy method'}, {'measure': 'The avoidance of semi-rigid thoracoscopy', 'timeFrame': '7 days after the procedure', 'description': 'The proportion of participants in the step-up arm who are diagnosed by UEPB alone and thus avoid semi-rigid thoracoscopy.'}, {'measure': 'The rate of unexpected chest tube drainage', 'timeFrame': '7 days after procedure', 'description': 'Any chest tube placement after UEPB or prolonged chest tube drainage (\\>24 hours) after semi-rigid thoracoscopy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pleural biopsy', 'Ultrasoinc elastography', 'Semi-rigid thoracoscopy'], 'conditions': ['Pleural Effusion Disorder']}, 'descriptionModule': {'briefSummary': 'Brief Summary\n\nThe goal of this clinical trial is to determine whether an initial diagnostic approach using ultrasound elastography-guided pleural biopsy (UEPB) is non-inferior to immediate medical thoracoscopic pleural biopsy in terms of diagnostic yield for obtaining a definitive histopathological diagnosis in patients with exudative pleural effusion of unclear etiology.\n\nThe main questions it aims to answer are:\n\nIs the step-up strategy (UEPB first, reserving thoracoscopy for non-diagnostic cases) non-inferior to immediate medical thoracoscopy in diagnostic yield?\n\nDoes the step-up strategy provide advantages in safety, patient tolerance, hospital stay, and cost-effectiveness compared to immediate thoracoscopy?\n\nResearchers will compare a step-up strategy (initial UEPB, followed by medical thoracoscopy if UEPB is non-diagnostic) versus immediate medical thoracoscopic pleural biopsy to see if the step-up approach achieves comparable diagnostic accuracy while potentially reducing procedure-related burden and healthcare resource use.\n\nParticipants will:\n\nBe randomly assigned in a 1:1 ratio to either the step-up strategy arm or the immediate medical thoracoscopy arm.\n\nIf assigned to the step-up arm: undergo UEPB under local anesthesia; if the biopsy is non-diagnostic, proceed to semi-rigid medical thoracoscopy.\n\nIf assigned to the immediate thoracoscopy arm: undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure.\n\nProvide tissue samples for histopathological, immunohistochemical, and molecular analyses as clinically indicated.\n\nComplete short-term follow-up at 7 days post-procedure (by telephone or clinic visit) to monitor adverse events and symptom recovery.\n\nIf initially diagnosed with non-specific benign disease or remain undiagnosed, complete a long-term follow-up at 12 months to establish a final diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Patients with exudative pleural effusion of unknown origin;\n3. Patients with negative pleural fluid cytology results;\n4. Patients who had not undergone pleural biopsy before enrolment.\n\nExclusion Criteria:\n\n1. Significantly bleeding risk, including uncorrectable coagulopathy (such as INR \\>1.5, platelet count \\<50×109 /L) or the need for ongoing anticoagulant/antiplatelet therapy that cannot be safely paused;\n2. Hemodynamic instability;\n3. Refractory hypoxemia despite supplemental oxygen;\n4. Any severe concurrent illness or cardiopulmonary compromise that, in the investigator's judgment, makes either procedural sedation (for thoracoscopy) or a bedside biopsy (for UEPB) unsafe;\n5. Pleural effusion conclusively identified as a transudate;\n6. Pregnancy or lactation;\n7. Any condition that, in the investigator's judgment, would compromise protocol compliance or follow-up."}, 'identificationModule': {'nctId': 'NCT07419620', 'briefTitle': 'Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion', 'orgStudyIdInfo': {'id': 'UPDATE-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Step-up strategy', 'description': 'Participants in this arm will first undergo ultrasound elastography-guided pleural biopsy (UEPB) under local anaesthesia. If the biopsy specimen is non-diagnostic, participants will proceed to semi-rigid medical thoracoscopic pleural biopsy under local anaesthesia or moderate sedation.', 'interventionNames': ['Procedure: Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immidiate semi-rigid thoracoscopy', 'description': 'Participants in this arm will undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. The procedure is performed under local anaesthesia or moderate sedation. Biopsy specimens are obtained under direct visualization from macroscopically abnormal pleural areas.', 'interventionNames': ['Procedure: Semi-rigid thoracoscopic pleural biopsy']}], 'interventions': [{'name': 'Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy', 'type': 'PROCEDURE', 'description': 'Participants receive ultrasound elastography-guided pleural biopsy (UEPB) as the first diagnostic procedure. If the UEPB specimen is non-diagnostic, participants proceed to semi-rigid medical thoracoscopic pleural biopsy.', 'armGroupLabels': ['Step-up strategy']}, {'name': 'Semi-rigid thoracoscopic pleural biopsy', 'type': 'PROCEDURE', 'description': 'Participants receive semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. The procedure is performed under local anaesthesia or moderate sedation, with biopsies obtained under direct visualization. A chest tube is inserted prophylactically following biopsy; chemical pleurodesis may be performed during the same procedure if clinically indicated.', 'armGroupLabels': ['Immidiate semi-rigid thoracoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Mingming Deng', 'role': 'CONTACT', 'email': 'isdeng1017@163.com', 'phone': '+86 18801336854'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Mingming Deng', 'role': 'CONTACT', 'email': 'isdeng1017@163.com', 'phone': '+86 18801336854'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gang Hou', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}