Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-04 @ 11:04 AM
Study NCT ID:
NCT02825095
Status:
UNKNOWN
Last Update Posted:
2016-07-07
First Post:
2016-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D015505', 'term': 'Chest Tubes'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Quality of Life', 'timeFrame': 'one year of regular follow up.', 'description': 'the patients will be followed up 14 days post intervention, 30 days, once monthly for 12 months, the patient will fill questioner every month evaluating the quality of life, the daily activities and the degree of shortness of breath.'}], 'secondaryOutcomes': [{'measure': 'procedure and admissions', 'timeFrame': 'one year', 'description': 'The patients will be evaluated for the number of admissions: e.g: how many times he/she was admitted to the hospital, duration of admissions; how many days he was admitted in the hospital each time and procedure related to pleural effusion; types and number of procedures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malignant pleural effusion,talc pleurodesis,quality of life'], 'conditions': ['Pleural Effusion, Malignant', 'Lung Neoplasms']}, 'referencesModule': {'references': [{'pmid': '18241636', 'type': 'BACKGROUND', 'citation': 'Heffner JE, Klein JS. Recent advances in the diagnosis and management of malignant pleural effusions. Mayo Clin Proc. 2008 Feb;83(2):235-50. doi: 10.4065/83.2.235.'}, {'pmid': '20696691', 'type': 'BACKGROUND', 'citation': 'Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.'}, {'pmid': '9272937', 'type': 'BACKGROUND', 'citation': 'Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. doi: 10.1183/09031936.97.10081907.'}, {'pmid': '20544327', 'type': 'BACKGROUND', 'citation': 'Uzbeck MH, Almeida FA, Sarkiss MG, Morice RC, Jimenez CA, Eapen GA, Kennedy MP. Management of malignant pleural effusions. Adv Ther. 2010 Jun;27(6):334-47. doi: 10.1007/S12325-010-0031-8. Epub 2010 Jun 10.'}, {'pmid': '930945', 'type': 'BACKGROUND', 'citation': 'Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.'}, {'pmid': '11069845', 'type': 'BACKGROUND', 'citation': 'American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. doi: 10.1164/ajrccm.162.5.ats8-00. No abstract available.'}, {'pmid': '24920947', 'type': 'BACKGROUND', 'citation': 'Nam HS. Malignant pleural effusion: medical approaches for diagnosis and management. Tuberc Respir Dis (Seoul). 2014 May;76(5):211-7. doi: 10.4046/trd.2014.76.5.211. Epub 2014 May 29.'}, {'pmid': '24102015', 'type': 'BACKGROUND', 'citation': 'Zarogoulidis K, Zarogoulidis P, Darwiche K, Tsakiridis K, Machairiotis N, Kougioumtzi I, Courcoutsakis N, Terzi E, Zaric B, Huang H, Freitag L, Spyratos D. Malignant pleural effusion and algorithm management. J Thorac Dis. 2013 Sep;5 Suppl 4(Suppl 4):S413-9. doi: 10.3978/j.issn.2072-1439.2013.09.04.'}, {'pmid': '19839739', 'type': 'BACKGROUND', 'citation': 'Olden AM, Holloway R. Treatment of malignant pleural effusion: PleuRx catheter or talc pleurodesis? A cost-effectiveness analysis. J Palliat Med. 2010 Jan;13(1):59-65. doi: 10.1089/jpm.2009.0220.'}, {'pmid': '21460729', 'type': 'BACKGROUND', 'citation': 'Chee A, Tremblay A. The use of tunneled pleural catheters in the treatment of pleural effusions. Curr Opin Pulm Med. 2011 Jul;17(4):237-41. doi: 10.1097/MCP.0b013e3283463dac.'}, {'pmid': '23616967', 'type': 'BACKGROUND', 'citation': 'Srour N, Amjadi K, Forster A, Aaron S. Management of malignant pleural effusions with indwelling pleural catheters or talc pleurodesis. Can Respir J. 2013 Mar-Apr;20(2):106-10. doi: 10.1155/2013/842768.'}]}, 'descriptionModule': {'briefSummary': 'Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion', 'detailedDescription': 'Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.\n\nThe two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.\n\nThe patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.\n\n * patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.\n * pleural biopsy - surgically obtained - with diagnosis of pleural malignancy\n * microscopic intraoperative findings suggestive of pleural malignancy.\n2. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.\n3. Patients with rate of fluid accumulation less than 30 days.\n4. Patient who signed informed consent about being involved in the study.\n\nExclusion Criteria:\n\n1. Patients under the age of 18 years.\n2. Female patients who are Pregnant or nursing.\n3. Patients with rate of pleural effusion accumulation is more than 30 days.\n4. Patients who didn't show clinical improvement post proper draining of the fluid\n5. Patients who are hemodynamically or respiratory unstable.\n6. Patients with Empyema.\n7. Patients who are non functioning/ not active according to the Performance status.\n8. The type of malignancy which cause the malignant pleural effusion is Lymphoma.\n9. Patient who underwent pneumonectomy at the side of the fluid.\n10. previous pleurodesis at the side of pleural effusion.\n11. Chylothorax in the initial pleural tapping."}, 'identificationModule': {'nctId': 'NCT02825095', 'briefTitle': 'Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.', 'orgStudyIdInfo': {'id': '0371-15rmb'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Talc Pleurodesis', 'description': 'For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.\n\nIf the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.', 'interventionNames': ['Procedure: Talc Pleurodesis', 'Procedure: chest ultrasound', 'Drug: Local anesthesia', 'Procedure: Chest Tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indwelling Pleural Catheter', 'description': 'All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.\n\nthe patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.\n\nthe duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.', 'interventionNames': ['Procedure: Indwelling Pleural Catheter', 'Procedure: chest ultrasound', 'Drug: Local anesthesia']}], 'interventions': [{'name': 'Talc Pleurodesis', 'type': 'PROCEDURE', 'description': 'chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed', 'armGroupLabels': ['Talc Pleurodesis']}, {'name': 'Indwelling Pleural Catheter', 'type': 'PROCEDURE', 'description': 'Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.', 'armGroupLabels': ['Indwelling Pleural Catheter']}, {'name': 'chest ultrasound', 'type': 'PROCEDURE', 'description': 'All insertion of a chest drain will be guided by ultrasound', 'armGroupLabels': ['Indwelling Pleural Catheter', 'Talc Pleurodesis']}, {'name': 'Local anesthesia', 'type': 'DRUG', 'otherNames': ['Lidocaine hydrochloride', 'Esracain injection 2%'], 'description': 'Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%', 'armGroupLabels': ['Indwelling Pleural Catheter', 'Talc Pleurodesis']}, {'name': 'Chest Tube', 'type': 'PROCEDURE', 'otherNames': ['PIGTAIL'], 'description': 'chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed', 'armGroupLabels': ['Talc Pleurodesis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ran Kremer, MD', 'role': 'CONTACT', 'email': 'r_kremer@rambam.health.gov.il', 'phone': '00972502063189'}, {'name': 'Amit Katz, MD', 'role': 'CONTACT', 'email': 'amit160275@gmail.com', 'phone': '00972502062291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}