Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-29 @ 1:18 PM
Study NCT ID:
NCT03828903
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2019-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Cryobiopsy in Diagnosis of 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-26', 'studyFirstSubmitDate': '2019-01-26', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.', 'timeFrame': '12 months', 'description': '1\\_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).'}], 'secondaryOutcomes': [{'measure': 'Complication assessment', 'timeFrame': '12 months', 'description': 'To evaluate the safety and occurrence of complication such as bleeding Number of patients with a certain degree of bleeding from biopsy site, described as:\n\n1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resuscitation .'}, {'measure': 'assessment pleural fluid', 'timeFrame': '12 months', 'description': 'comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.'}, {'measure': 'assessment of post procedure pain', 'timeFrame': '12 months', 'description': 'comparison between meperidine and (midazolam \\&NSAIDs) in controlling pain post thoracoscopy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryobiopsy'], 'conditions': ['Pleural Effusion']}, 'referencesModule': {'references': [{'pmid': '29610630', 'type': 'BACKGROUND', 'citation': 'Chen CH, Cheng WC, Wu BR, Chen CY, Chen WC, Liao WC, Tu CY. Feasibility and Safety of Pleuroscopic Cryobiopsy of the Pleura: A Prospective Study. Can Respir J. 2018 Jan 22;2018:6746470. doi: 10.1155/2018/6746470. eCollection 2018.'}, {'pmid': '29261578', 'type': 'BACKGROUND', 'citation': 'Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.', 'detailedDescription': '* Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or pethidin.\n* vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.\n* Then the trocar will be inserted until the sudden release of resistance (after passing the costal pleura) is felt.\n* Under direct vision with the thoracoscope, introduction of pneumothorax will be performed, and all pleural fluid will be removed, and the pleural cavity will be inspected.\n* Suspicious areas will be biopsied through the working channel of the thoracoscope.\n* two to six biopsies of a suspicious pleural lesion will establish the diagnosis.\n\nTechnique of pleural biopsy using cryotechnique:\n\n* The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.\n* The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch.\n* carbon dioxide will be used as the cryogen gas for cryobiopsy\n* The frozen tissue is going to be extracted by gently pulling of the probe.\n* Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.\n\n3\\. Age\\>18 years old\n\nExclusion Criteria:\n\n1. Transudative pleural effusion.\n2. Exudative pleural effusion less than one third of hemithorax.\n3. Presence of hemorrhagic diathesis (prothrombin concentration \\<50% and platelet count \\<80,000/mm 3).\n4. Poor performance state (ECOG performance status \\>4) as recommended in BTS (British thoracic society) guidelines 2010.\n5. Sever uncontrollable cough, hypercapnia and sever respiratory distress.\n6. Fibrothorax, excessive pleural adhesion.\n\n \\-"}, 'identificationModule': {'nctId': 'NCT03828903', 'briefTitle': 'Role of Cryobiopsy in Diagnosis of Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion', 'orgStudyIdInfo': {'id': 'Cryobiopsy pleural effusion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pleural effusion patients', 'description': 'medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained', 'interventionNames': ['Device: Cryoprobe']}], 'interventions': [{'name': 'Cryoprobe', 'type': 'DEVICE', 'description': '* The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.\n* The tip of the cryoprobe will be attached to suspicious part of parietal pleura .\n* The frozen tissue is going to be extracted by gently pulling of the probe.\n* Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.\n* The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar.\n* The biopsy sample will be released from the probe by thawing in the saline.\n* The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding.', 'armGroupLabels': ['pleural effusion patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit University hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Asyut', 'country': 'Egypt', 'facility': 'Alaa Salah Abdel gany', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Reham M El morshedy, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer, Chest Department and tuberculosis', 'investigatorFullName': 'Alaa Salah Abd El Ghany', 'investigatorAffiliation': 'Assiut University'}}}}