Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 3:41 AM
Study NCT ID:
NCT04761003
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2021-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A full medical history was obtained. Medical history, clinical examination and local chest examination for signs of pleural effusion, Radiological data include chest X-ray, chest computed tomography (CT), and chest ultrasound (US) for localization of a better entry site.\n\nThoracoscopy procedure the procedure was performed in the lateral decubitus position with the affected side upward under conscious sedation. Local anesthesia consisting of 2% lignocaine was administered to the skin, subcutaneous tissue, muscle, and parietal pleura.\n\nThe appearance of the parietal and visceral pleural was assessed and recorded. Pleural biopsies were obtained using rigid forceps and cryoprobe during rigid medical thoracoscopy Complications during thoracoscopy were recorded as bleeding and surgical emphysema.\n\nSamples were directly fixed in 10% formalin solution Biopsies obtained were examined pathologically with stress on size and quality of the sample.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2021-02-14', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy which determined by the diagnostic yield', 'timeFrame': 'baseline', 'description': 'comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.'}, {'measure': 'efficacy which determined by the size of biopsy', 'timeFrame': 'baseline', 'description': 'comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.'}, {'measure': 'The incidence of complications', 'timeFrame': 'baseline', 'description': 'comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleura; Exudate']}, 'referencesModule': {'references': [{'pmid': '12806235', 'type': 'RESULT', 'citation': 'Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.'}, {'pmid': '21213207', 'type': 'RESULT', 'citation': 'Noppen M. The utility of thoracoscopy in the diagnosis and management of pleural disease. Semin Respir Crit Care Med. 2010 Dec;31(6):751-9. doi: 10.1055/s-0030-1269835. Epub 2011 Jan 6.'}, {'pmid': '23411054', 'type': 'RESULT', 'citation': 'Porcel JM. Pleural fluid biomarkers: beyond the Light criteria. Clin Chest Med. 2013 Mar;34(1):27-37. doi: 10.1016/j.ccm.2012.11.002. Epub 2013 Jan 17.'}, {'pmid': '29261578', 'type': 'RESULT', '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.'}, {'pmid': '2920573', 'type': 'RESULT', 'citation': 'Bonniot JP, Homasson JP, Roden SL, Angebault ML, Renault PC. Pleural and lung cryobiopsies during thoracoscopy. Chest. 1989 Mar;95(3):492-3. doi: 10.1378/chest.95.3.492.'}, {'pmid': '18708736', 'type': 'RESULT', 'citation': 'Hetzel J, Hetzel M, Hasel C, Moeller P, Babiak A. Old meets modern: the use of traditional cryoprobes in the age of molecular biology. Respiration. 2008;76(2):193-7. doi: 10.1159/000135934. Epub 2008 Jun 26.'}, {'pmid': '16623208', 'type': 'RESULT', 'citation': 'Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion', 'detailedDescription': 'Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study\n\nExclusion Criteria:\n\n* patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space"}, 'identificationModule': {'nctId': 'NCT04761003', 'briefTitle': 'Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion', 'orgStudyIdInfo': {'id': 'Thoracoscopic cryobiopsy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (Cryobiopsy group):', 'description': 'patients where patients will be subjected to thoracoscopic cryobiopsy.', 'interventionNames': ['Device: Thoracoscopy forceps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (Forceps group)', 'description': 'patients where patients will be subjected to thoracoscopic forceps biopsy.', 'interventionNames': ['Device: Thoracoscopy forceps']}], 'interventions': [{'name': 'Thoracoscopy forceps', 'type': 'DEVICE', 'otherNames': ['Thoracoscopic cryobiopsy'], 'description': 'take pleural biopsy', 'armGroupLabels': ['Group I (Cryobiopsy group):', 'Group II (Forceps group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Raed E ALI, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}, {'name': 'Ahmed E Mansour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tamer Awad', 'investigatorAffiliation': 'Mansoura University'}}}}