Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01409551
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2011-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of pleural effusion', 'timeFrame': '2 months following intervention'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'Postoperative period (7 days following intervention)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pleural effusion', 'VATS', 'hyperthermia', 'thoracostomy', 'pleurodesis'], 'conditions': ['Safety of Intervention', 'Efficacy of Intervention', 'Cost Effectiveness']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.', 'detailedDescription': 'The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent symptomatic malignant pleural effusion\n* No prior intrapleural therapy\n* Abscence of bronchial obstruction or fibrosis preventing lung reexpansion\n* No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis\n\nExclusion Criteria:\n\n* Poor Karnofsky Performance Status'}, 'identificationModule': {'nctId': 'NCT01409551', 'briefTitle': 'Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Theagenio Cancer Hospital'}, 'officialTitle': 'Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.', 'orgStudyIdInfo': {'id': 'Theagenio Thoracic Surgery 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VATS hyperthermic pleural chemoperfusion', 'description': 'The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine.', 'interventionNames': ['Procedure: VATS hyperthermic chemoperfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bedside talc slurry pleurodesis', 'description': 'The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.', 'interventionNames': ['Procedure: Bedside talc slurry pleurodesis']}], 'interventions': [{'name': 'VATS hyperthermic chemoperfusion', 'type': 'PROCEDURE', 'description': 'VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)', 'armGroupLabels': ['VATS hyperthermic pleural chemoperfusion']}, {'name': 'Bedside talc slurry pleurodesis', 'type': 'PROCEDURE', 'description': 'Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.', 'armGroupLabels': ['Bedside talc slurry pleurodesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54007', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Thoracic Surgery Department, Theagenio Cancer Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Nikolaos Barbetakis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Theagenio Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theagenio Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Thoracic Surgery Department', 'investigatorFullName': 'Nikolaos Barbetakis', 'investigatorAffiliation': 'Theagenio Cancer Hospital'}}}}