Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 1:11 PM
Study NCT ID:
NCT01726556
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2012-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-09', 'studyFirstSubmitDate': '2012-11-07', 'studyFirstSubmitQcDate': '2012-11-10', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Use of sedation and analgesia during the procedure', 'timeFrame': 'At the end of procedure', 'description': 'The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms'}, {'measure': "Operators' experience characteristics", 'timeFrame': 'At the end of the procedure', 'description': "These would include, on a numerical scale of 0 to 100, the operator's grading of the following characteristics: quality of thoracoscopic image, ease of maneuvering, ease of taking a biopsy and the operator's expectation that the biopsy will reveal a definitive histological diagnosis"}], 'primaryOutcomes': [{'measure': 'Diagnostic yield of thoracoscopic biopsy by intention to treat analysis', 'timeFrame': '3 months', 'description': 'The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms'}], 'secondaryOutcomes': [{'measure': 'Yield of biopsies successfully completed', 'timeFrame': '3 months', 'description': 'The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms'}, {'measure': 'Complications', 'timeFrame': '3 months', 'description': 'Number of major and minor complications encountered in the two arms'}, {'measure': 'Scar size', 'timeFrame': 'At the end of the procedure', 'description': 'Scar size (in mm) in the longest axis'}, {'measure': 'Biopsy size', 'timeFrame': 'At the end of the procedure', 'description': 'Biopsy size (in mm) in the longest axis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pleural effusion', 'Semirigid thoracoscopy', 'Rigid thoracoscopy'], 'conditions': ['Pleurisy With Effusion']}, 'referencesModule': {'references': [{'pmid': '24106326', 'type': 'DERIVED', 'citation': 'Dhooria S, Singh N, Aggarwal AN, Gupta D, Agarwal R. A randomized trial comparing the diagnostic yield of rigid and semirigid thoracoscopy in undiagnosed pleural effusions. Respir Care. 2014 May;59(5):756-64. doi: 10.4187/respcare.02738. Epub 2013 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination\n\nExclusion Criteria:\n\n* Significant hypoxemia on room air\n* Hemodynamic instability\n* Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)\n* Refractory cough\n* Lack of pleural space due to adhesions\n* Uncorrected coagulopathy"}, 'identificationModule': {'nctId': 'NCT01726556', 'acronym': 'RISE', 'briefTitle': 'A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions', 'orgStudyIdInfo': {'id': '1Trg-PG-2012/5054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rigid thoracoscopy', 'description': 'Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.', 'interventionNames': ['Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Semirigid thoracoscopy', 'description': 'The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.', 'interventionNames': ['Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)']}], 'interventions': [{'name': 'Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)', 'type': 'DEVICE', 'description': 'Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany', 'armGroupLabels': ['Rigid thoracoscopy']}, {'name': 'Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)', 'type': 'DEVICE', 'description': 'Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan', 'armGroupLabels': ['Semirigid thoracoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Ritesh Agarwal, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PGIMER, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Resident', 'investigatorFullName': 'Sahajal Dhooria', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}