Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT03449602
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2018-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2018-02-17', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic sensitivity (intention-to-treat)', 'timeFrame': '6 months', 'description': 'Difference between the diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracoscopic biopsy in the two groups out of the total diseased'}, {'measure': 'Diagnostic sensitivity (per protocol)', 'timeFrame': '6 months', 'description': 'Diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracocopic biopsy. In this analysis, the subjects crossed over to the rigid group (due to failure of minirigid to yield biopsy tissue) will be considered in the rigid group'}], 'secondaryOutcomes': [{'measure': 'Sedative and analgesic dose', 'timeFrame': '1 day', 'description': 'Comparing doses of sedative and analgesic agents required in the two groups'}, {'measure': 'Pain scores by visual analog scale', 'timeFrame': '1 day', 'description': 'Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the visual analog scale from 0-no pain to 100-maximum possible pain) in the two groups'}, {'measure': 'Diagnostic specificity', 'timeFrame': '6 months', 'description': 'Difference between the diagnostic specificity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true negatives diagnosed by thoracoscopic biopsy in the two groups out of those not diseased'}, {'measure': 'Adverse effects', 'timeFrame': '1 month', 'description': 'Differences between number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the two groups'}, {'measure': 'Scope maneuverability', 'timeFrame': '1 day', 'description': 'Differences between maneuverability of the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator'}, {'measure': 'Ease of obtaining biopsy', 'timeFrame': '1 day', 'description': 'Differences between ease of obtaining pleural biopsy with the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator'}, {'measure': 'Incision size', 'timeFrame': '1 day', 'description': 'Difference in the size of the incision required with the use of the two devices'}, {'measure': 'Procedure duration', 'timeFrame': '1 day', 'description': 'Difference in the duration of procedure in the two groups'}, {'measure': 'Pain scores by Wong Baker FACES pain rating scale', 'timeFrame': '1 day', 'description': 'Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the Wong Baker FACES pain rating scale) in the two groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thoracoscopy', 'pleuroscopy', 'metastatic cancer', 'lung cancer', 'malignant pleural effusion', 'tuberculosis'], 'conditions': ['Pleural Effusion']}, 'descriptionModule': {'briefSummary': 'Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study.\n\nOne hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups:\n\nGroup A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions', 'detailedDescription': 'A significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. In this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope.\n\nThis is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh.\n\nConsecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study\n\nOne hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups:\n\nGroup A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.\n\nGroup B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm.\n\nPrimary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical thoracoscopy being performed for obtaining a pleural biopsy\n\nExclusion Criteria:\n\n* PaO2/FIO2\\< 300; Hemodynamic instability Myocardial infarction or unstable angina in the last 6 wk Lack of pleural space due to adhesions Uncorrected coagulopathy Failure to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03449602', 'acronym': 'MICRO', 'briefTitle': 'Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions', 'orgStudyIdInfo': {'id': 'NK/3695/Res'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mini-thoraoscopy', 'description': 'The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.', 'interventionNames': ['Device: Mini-thoracoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional rigid thoracoscopy', 'description': 'The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 10 mm and channel internal diameter of 5 mm.', 'interventionNames': ['Device: Conventional rigid thoraoscopy']}], 'interventions': [{'name': 'Mini-thoracoscopy', 'type': 'DEVICE', 'description': 'Thoracoscopic pleural biopsy with the mini-thoracoscope', 'armGroupLabels': ['Mini-thoraoscopy']}, {'name': 'Conventional rigid thoraoscopy', 'type': 'DEVICE', 'description': 'Thoracoscopic pleural biopsy with the conventional rigid thoraoscope', 'armGroupLabels': ['Conventional rigid thoracoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Digambar Behera, MD', 'role': 'CONTACT', 'email': 'dirlrsi@gmail.com', 'phone': '+911722756822'}], 'facility': 'Postgraduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Sahajal Dhooria, MD, DM', 'role': 'CONTACT', 'email': 'sahajal@gmail.com', 'phone': '+919530661388'}, {'name': 'Ritesh Agarwal, MD, DM', 'role': 'CONTACT', 'email': 'agarwal.ritesh@outlook.in', 'phone': '+919478402976'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sahajal Dhooria', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}