Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT01366261
Status:
COMPLETED
Last Update Posted:
2011-11-11
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-09', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic adequacy of semirigid thoracoscopy', 'timeFrame': '12 months', 'description': '* comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group)\n* size of the biopsy specimens in mm2\n* interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)'}], 'secondaryOutcomes': [{'measure': 'safety', 'timeFrame': '1 month', 'description': 'Major adverse events:\n\n* bleeding\n* infection\n* reexpansion pulmonary edema\n\nMinor adverse events:\n\n* transient self-limited fever\n* pain\n* prolongued air leak\n* subcutaneous emphysema\n\n 30-day mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Flex-rigid pleuroscopy', 'pleural biopsy', 'pleural effusion', 'safety', 'thoracoscopy'], 'conditions': ['Pleural Diseases']}, 'referencesModule': {'references': [{'pmid': '23418922', 'type': 'DERIVED', 'citation': 'Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 or more years old\n* unilateral pleural effusion of unknown origin\n* pleural irregularities suspicious for pleural malignancy\n* referral for thoracoscopy after less invasive means of diagnosis had failed\n\nExclusion Criteria:\n\n* uncontrolled bleeding tendency\n* unstable cardiovascular status\n* severe heart failure\n* ECOG performance status 4\n* persistent hypoxemia after evacuation of pleural fluid'}, 'identificationModule': {'nctId': 'NCT01366261', 'briefTitle': 'Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}, 'officialTitle': 'Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study', 'orgStudyIdInfo': {'id': 'endo-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'semirigid thoracoscopy', 'description': 'Semirigid instrument which we compare was autoclavable Olympus LTF-160 (Olympus Tokyo, Japan). Handle and its controls were similar to flexible fiberoptic bronchoscope, with the insertion portion composed of 22 cm long rigid part and distal 5 cm flexible tip with angulation range 1600 up / 1300 down. The external diameter of insertion portion was 7 mm with 2,8 mm inner channel diameter. The instrument was compatible with Olympus EVIS Exera 160 and 145 and EVIS 100 and 140 video processors and light sources, otherwise employed in video-bronchoscopy. Forceps, which we used was flexible FB-55CD-1 Olympus forceps with 5 mm long cusps and diameter, which fitted the diameter of inner channel of semirigid thoracoscope.', 'interventionNames': ['Device: semirigid thoracoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rigid thoracoscopy', 'description': 'The rigid instrument was autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope. The length of the instrument was 29 cm with 00 direction of view and 700 field of view. The external diameter of the instrument was 10 mm with 5,2 mm inner channel diameter. The instrument was compatible with Olympus Visera OTV-S7V and EVIS Exera II CV-180 video processors. Cusps of rigid forceps had outer diameter 5 mm and length 10 mm.', 'interventionNames': ['Device: rigid thoracoscopy']}], 'interventions': [{'name': 'semirigid thoracoscopy', 'type': 'DEVICE', 'otherNames': ['autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)'], 'description': 'thoracoscopy with semirigid instrument', 'armGroupLabels': ['semirigid thoracoscopy']}, {'name': 'rigid thoracoscopy', 'type': 'DEVICE', 'otherNames': ['autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope'], 'description': 'thoracoscopy with rigid instrument', 'armGroupLabels': ['rigid thoracoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4204', 'city': 'Golnik', 'state': 'Golnik', 'country': 'Slovenia', 'facility': 'University Clinic Golnik', 'geoPoint': {'lat': 46.33333, 'lon': 14.33333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aleš Rozman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Aleš Rozman', 'investigatorAffiliation': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}}}}