Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04074902
Status:
UNKNOWN
Last Update Posted:
2019-08-30
First Post:
2019-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate and compare the outcome of pleurodisis by different modalities.', 'timeFrame': 'baseline', 'description': 'To compare chest sonographic findings versus Multislice CT findings in detecting endobronchial obstruction in patients with malignant pleural effusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleurodesis']}, 'referencesModule': {'references': [{'pmid': '30243566', 'type': 'BACKGROUND', 'citation': 'Corcoran JP, Hallifax RJ, Mercer RM, Yousuf A, Asciak R, Hassan M, Piotrowska HE, Psallidas I, Rahman NM. Thoracic Ultrasound as an Early Predictor of Pleurodesis Success in Malignant Pleural Effusion. Chest. 2018 Nov;154(5):1115-1120. doi: 10.1016/j.chest.2018.08.1031. Epub 2018 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'Thoracic ultrasonography easily detects the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful.', 'detailedDescription': "Malignant pleural effusion (MPE) imposes a significant burden on patients and health-care providers. Most of the malignant pleural effusions are the result of metastases to the pleura from other sites. The primary tumors were, in the decreasing order of frequency: lung (37%), breast (17%), unknown site (10%), lymphoma (9%), gastrointestinal (8%), ovary (7%) and mesothelioma (3%) .\n\nManagement of malignant effusions depends on palliation of dyspnea and prevention of the re accumulation of pleural fluid to provide the highest possible quality of life, regardless of the need for other treatment modalities. Most patients require definitive treatment, usually drainage and chemical pleurodesis to relieve symptoms and prevent fluid recurrence. Pleurodesis is defined as the symphysis between the visceral and parietal pleural surfaces; its function is to prevent accumulation of either air or fluid into the pleural space. Effusions of malignant origin are the most common indication for pleurodesis Thoracic ultrasound (TUS) can easily visualize pleural effusions and help in identifying malignant effusion and the presence of pleural adhesions or thick pleural peel and could therefore have a role in predicting long-term pleurodesis success or failure in MPE.\n\nOne of the easiest sign to identify during chest sonography is the movement of the visceral pleura compared to immobility of the parietal pleura. This sign of 'pleural sliding', firstly described in veterinary medicine and was used to exclude the presence of pneumothorax when present and to suspect atelectasis, fibrosis or pleural adhesions (pleurodesis) when absent. Thoracic ultrasonography easily detects the sign of 'pleural sliding', due to the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful. Contrast-enhanced chest CT has become the imaging modality of choice to detect pleural effusions and assist the differentiation between benign andmalignant effusions detected bystandard radiographs. Chest CT findings characteristic of malignant pleural disease include (i) circumferential pleural thickening, (ii) nodular pleural thickening, (iii) parietal pleural thickening greater than 1 cm, and (iv) mediastinal pleural involvement or evidence of a primary tumour.(9'10) The reported specificities of each of these individual findings range from 22% to 56% and sensitivities range from 88% to 100%.(9;11) Histological confirmation of the diagnosis, however, remains necessary. Chest CT should be performed before large-volume thoracocentesis to allow visualization of both the visceral and parietal pleurae, which may identify a pleural mass and appropriate site for needle biopsy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 patients will be chosen at random for one year from the start of the study and will be recruited from chest out patient clinc and department Assiut University hospital which are eligible for this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with malignant pleural effusion who will undergo palliative treatment with insertion of intercostal tube.\n\nExclusion Criteria:\n\n1. Patients \\<18 years old, unable to provide informed consent.\n2. Had an allergy or other contraindication to intrapleural pleurodesis.\n3. Had evidence of unexpandable lung believed by the responsible clinician to represent insufficient.\n4. pleural apposition that would preclude pleurodesis, and/or had an expected survival of\\<1 month.'}, 'identificationModule': {'nctId': 'NCT04074902', 'briefTitle': 'Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Chest Sonography in Evaluation of Successful Pleurodesis in Patients With Malignant Pleural Effusion', 'orgStudyIdInfo': {'id': 'Ultrasaund after pleurodesis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasonography', 'type': 'DEVICE', 'description': 'Mindray dp1100 plus.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Safaa Ahmed EL-Sagheir Adam', 'investigatorAffiliation': 'Assiut University'}}}}