Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 9:23 PM
Study NCT ID:
NCT01469728
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-10-28', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of perioperative medical care (PMC).', 'timeFrame': 'participants are followed for the duration of hospital stay; average of 5 days', 'description': 'PMC is aimed at evaluating the overall workload in medical care throughout the the entire perioperative period and until discharge. PMC was computed as a comprehensive multidimensional variable including hospitalization time and extra-routine nursing/clinical/pharmacological requirements and costs(grades 1-3).'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Postoperatively at 3h,12h and 24h'}, {'measure': 'Perioperative changes in blood gases', 'timeFrame': 'Imediately before operation, at end-procedure, postoperatively at 1h and 24h', 'description': 'Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)'}, {'measure': 'Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)', 'timeFrame': 'Immediately before the operation, at end-procedure, postoperatively at 1h and 24h'}, {'measure': 'Postoperative changes in spirometric variables', 'timeFrame': 'Postoperatively at 3h,12h and 24h', 'description': 'Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)'}, {'measure': 'Morbidity', 'timeFrame': 'from day of operation to discharge; average, 5 days'}, {'measure': 'Hospital stay', 'timeFrame': 'from day of operation to discharge; average, 5 days'}, {'measure': 'Redo pleurodesis', 'timeFrame': 'From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause', 'description': 'Need of reoperation because of recurrence of the pleural effusion'}, {'measure': 'Operative mortality', 'timeFrame': 'from day of operation for up to 30 days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VATS', 'awake thoracic surgery', 'pleurodesis', 'talc', 'TEA', 'epidural anesthesia', 'Video-Assisted', 'Anesthesia Epidural'], 'conditions': ['Pleural Effusion']}, 'referencesModule': {'references': [{'pmid': '21397783', 'type': 'BACKGROUND', 'citation': 'Pompeo E, Tacconi F, Mineo TC. Comparative results of non-resectional lung volume reduction performed by awake or non-awake anesthesia. Eur J Cardiothorac Surg. 2011 Apr;39(4):e51-8. doi: 10.1016/j.ejcts.2010.11.071.'}, {'pmid': '20980159', 'type': 'BACKGROUND', 'citation': 'Pompeo E, Tacconi F, Frasca L, Mineo TC. Awake thoracoscopic bullaplasty. Eur J Cardiothorac Surg. 2011 Jun;39(6):1012-7. doi: 10.1016/j.ejcts.2010.09.029. Epub 2010 Oct 25.'}, {'pmid': '20732526', 'type': 'BACKGROUND', 'citation': 'Vanni G, Tacconi F, Sellitri F, Ambrogi V, Mineo TC, Pompeo E. Impact of awake videothoracoscopic surgery on postoperative lymphocyte responses. Ann Thorac Surg. 2010 Sep;90(3):973-8. doi: 10.1016/j.athoracsur.2010.04.070.'}, {'pmid': '20451133', 'type': 'BACKGROUND', 'citation': 'Pompeo E, Tacconi F, Mineo TC. Awake video-assisted thoracoscopic biopsy in complex anterior mediastinal masses. Thorac Surg Clin. 2010 May;20(2):225-33. doi: 10.1016/j.thorsurg.2010.01.003.'}, {'pmid': '20179134', 'type': 'BACKGROUND', 'citation': 'Tacconi F, Pompeo E, Sellitri F, Mineo TC. Surgical stress hormones response is reduced after awake videothoracoscopy. Interact Cardiovasc Thorac Surg. 2010 May;10(5):666-71. doi: 10.1510/icvts.2009.224139. Epub 2010 Feb 23.'}, {'pmid': '19762250', 'type': 'BACKGROUND', 'citation': 'Tacconi F, Pompeo E, Fabbi E, Mineo TC. Awake video-assisted pleural decortication for empyema thoracis. Eur J Cardiothorac Surg. 2010 Mar;37(3):594-601. doi: 10.1016/j.ejcts.2009.08.003. Epub 2009 Sep 16.'}, {'pmid': '18831509', 'type': 'BACKGROUND', 'citation': 'Pompeo E, Mineo TC. Awake operative videothoracoscopic pulmonary resections. Thorac Surg Clin. 2008 Aug;18(3):311-20. doi: 10.1016/j.thorsurg.2008.04.006.'}, {'pmid': '18036900', 'type': 'BACKGROUND', 'citation': 'Pompeo E, Mineo TC. Two-year improvement in multidimensional body mass index, airflow obstruction, dyspnea, and exercise capacity index after nonresectional lung volume reduction surgery in awake patients. Ann Thorac Surg. 2007 Dec;84(6):1862-9; discussion 1862-9. doi: 10.1016/j.athoracsur.2007.07.007.'}, {'pmid': '23601750', 'type': 'DERIVED', 'citation': 'Pompeo E, Dauri M; Awake Thoracic Surgery Research Group. Is there any benefit in using awake anesthesia with thoracic epidural in thoracoscopic talc pleurodesis? J Thorac Cardiovasc Surg. 2013 Aug;146(2):495-7.e1. doi: 10.1016/j.jtcvs.2013.03.038. Epub 2013 Apr 17. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence.\n\nGeneral anesthesia and one lung ventilation is the standard type of anesthesia employed for VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating patients is being increasingly employed to perform several cardio-thoracic surgery procedures in an attempt of minimize operative risks and facilitate resumption of daily-life activity.\n\nThe investigators have reasoned that for a simple and palliative procedure such as talc pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might be considered a potential cause of morbidity and delayed recovery. The investigators have also hypothesized TEA could be considered an optimal type of anesthesia in this setting leading to a fast recovery a reduced overall workload in medical care.\n\nIn this single-center randomized study, the investigators have comparatively assessed the impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive results of VATS talc pleurodesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.\n* Karnofsky performance status ≥ 50\n* ASA score II-III\n* Acceptance of the randomly assigned anesthesia protocol\n* Radiologic evidence of lung re-expansion after previous drainage/thoracentesis\n* Absence of blood clotting disorders (INR \\< 1.5)\n* No contraindications to TEA\n* No neurological or psychiatric disturbance contraindicating awake surgery\n\nExclusion Criteria:\n\n* Patients refusal of random assignment to treatment arm\n* Patients refusal or noncompliance to TEA\n* Patients refusal or noncompliance to general anesthesia and one-lung ventilation\n* Unfavourable anatomy for TEA\n* Previous surgery of the thoracic spine\n* Coagulation disorders (thromboplastin time \\< 80%, prothrombin time \\> 40 sec, platelet count \\< 200/nL or bleeding disorders'}, 'identificationModule': {'nctId': 'NCT01469728', 'briefTitle': 'Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia', 'orgStudyIdInfo': {'id': '107/07'}, 'secondaryIdInfos': [{'id': '#20112', 'type': 'OTHER', 'domain': 'TOR VERGATA UNIVERSITY'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Awake VATS', 'description': 'Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.', 'interventionNames': ['Procedure: Awake VATS talc pleurodesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-awake VATS talc pleurodesis', 'description': 'Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation', 'interventionNames': ['Procedure: Non-awake VATS talc pleurodesis']}], 'interventions': [{'name': 'Non-awake VATS talc pleurodesis', 'type': 'PROCEDURE', 'description': 'Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation', 'armGroupLabels': ['Non-awake VATS talc pleurodesis']}, {'name': 'Awake VATS talc pleurodesis', 'type': 'PROCEDURE', 'description': 'Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.', 'armGroupLabels': ['Awake VATS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Tor Vergata University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Eugenio Pompeo', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}