Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT05781659
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 592}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.', 'timeFrame': '7 days after the biopsy', 'description': 'The diagnosis would be confirmed according to the pathological results.'}], 'secondaryOutcomes': [{'measure': 'Incidence rate of adverse events', 'timeFrame': '7 days after the biopsy', 'description': 'Symptoms and signs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleural Effusion']}, 'referencesModule': {'references': [{'pmid': '40935584', 'type': 'DERIVED', 'citation': 'Deng M, Xia Y, Ye X, Ma J, Zhao S, Zhang Q, Li J, Lin J, Jing A, Li ZY, Jiang B, Wu J, Wen Q, Ma J, Tong R, Zheng Z, Xu W, Li X, Herth FJ, Hou G. Ultrasonic Elastography-guided Pleural Biopsy versus Traditional Thoracic Ultrasound-guided Pleural Biopsy for the Diagnosis of Pleural Effusion: A Multicentre Randomized Trial. Eur Respir J. 2025 Sep 11:2501062. doi: 10.1183/13993003.01062-2025. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.\n\nParticipants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)\n2. Sign the informed consent form\n3. The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation\n\nExclusion Criteria:\n\n1. The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.\n2. The pleural fluid cytology proved to be malignant.\n3. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.\n4. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition\n5. Coagulation dysfunction.\n6. transudate\n7. The age is less than 18 years old.'}, 'identificationModule': {'nctId': 'NCT05781659', 'briefTitle': 'The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion', 'orgStudyIdInfo': {'id': '2022-NHLHCRF-LX-01-0201-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound elastography guided pleural biopsy group', 'interventionNames': ['Procedure: Ultrasound elastography guided pleural biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional ultrasound-guided pleural biopsy group', 'interventionNames': ['Procedure: Traditional ultrasound guided pleural biopsy']}], 'interventions': [{'name': 'Ultrasound elastography guided pleural biopsy', 'type': 'PROCEDURE', 'description': 'The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.', 'armGroupLabels': ['Ultrasound elastography guided pleural biopsy group']}, {'name': 'Traditional ultrasound guided pleural biopsy', 'type': 'PROCEDURE', 'description': 'The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.', 'armGroupLabels': ['Traditional ultrasound-guided pleural biopsy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tang Fei, MM', 'role': 'CONTACT'}], 'facility': 'Anhui Chest Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tong Run, MD', 'role': 'CONTACT'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '550000', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Xianwei, MD', 'role': 'CONTACT'}], 'facility': "Gui Zhou Provincial People's Hospital", 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Yan, MD', 'role': 'CONTACT'}], 'facility': 'the Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Fei, MD', 'role': 'CONTACT'}], 'facility': 'the First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ma Jiangwei, MD', 'role': 'CONTACT'}], 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LI Chengjun, MM', 'role': 'CONTACT'}], 'facility': "The Tenth People's Hospital of Shenyang", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Yunhui, MD', 'role': 'CONTACT'}], 'facility': "the First People's Hospital of Yunnan Provience", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xia Yang, MD', 'role': 'CONTACT'}], 'facility': 'the Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Mingming Deng, MD', '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'}}}}