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Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis

Primary Purpose

Pleural Effusion, Malignant, Lung Neoplasms

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Talc Pleurodesis
Indwelling Pleural Catheter
chest ultrasound
Local anesthesia
Chest Tube
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion, Malignant focused on measuring malignant pleural effusion,talc pleurodesis,quality of life

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.

    • patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.
    • pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
    • microscopic intraoperative findings suggestive of pleural malignancy.
  2. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
  3. Patients with rate of fluid accumulation less than 30 days.
  4. Patient who signed informed consent about being involved in the study.

Exclusion Criteria:

  1. Patients under the age of 18 years.
  2. Female patients who are Pregnant or nursing.
  3. Patients with rate of pleural effusion accumulation is more than 30 days.
  4. Patients who didn't show clinical improvement post proper draining of the fluid
  5. Patients who are hemodynamically or respiratory unstable.
  6. Patients with Empyema.
  7. Patients who are non functioning/ not active according to the Performance status.
  8. The type of malignancy which cause the malignant pleural effusion is Lymphoma.
  9. Patient who underwent pneumonectomy at the side of the fluid.
  10. previous pleurodesis at the side of pleural effusion.
  11. Chylothorax in the initial pleural tapping.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Talc Pleurodesis

    Indwelling Pleural Catheter

    Arm 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. If 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.

    All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia. the 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. the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.

    Outcomes

    Primary Outcome Measures

    change in Quality of Life
    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.

    Secondary Outcome Measures

    procedure and admissions
    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

    Full Information

    First Posted
    April 4, 2016
    Last Updated
    July 6, 2016
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02825095
    Brief Title
    Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis
    Official Title
    Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion
    Detailed Description
    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. The 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. The 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Effusion, Malignant, Lung Neoplasms
    Keywords
    malignant pleural effusion,talc pleurodesis,quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Talc Pleurodesis
    Arm Type
    Active Comparator
    Arm 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. If 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.
    Arm Title
    Indwelling Pleural Catheter
    Arm Type
    Active Comparator
    Arm Description
    All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia. the 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. the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.
    Intervention Type
    Procedure
    Intervention Name(s)
    Talc Pleurodesis
    Intervention 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
    Intervention Type
    Procedure
    Intervention Name(s)
    Indwelling Pleural Catheter
    Intervention Description
    Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.
    Intervention Type
    Procedure
    Intervention Name(s)
    chest ultrasound
    Intervention Description
    All insertion of a chest drain will be guided by ultrasound
    Intervention Type
    Drug
    Intervention Name(s)
    Local anesthesia
    Other Intervention Name(s)
    Lidocaine hydrochloride, Esracain injection 2%
    Intervention Description
    Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
    Intervention Type
    Procedure
    Intervention Name(s)
    Chest Tube
    Other Intervention Name(s)
    PIGTAIL
    Intervention 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
    Primary Outcome Measure Information:
    Title
    change in Quality of Life
    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.
    Time Frame
    one year of regular follow up.
    Secondary Outcome Measure Information:
    Title
    procedure and admissions
    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
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid. patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis. pleural biopsy - surgically obtained - with diagnosis of pleural malignancy microscopic intraoperative findings suggestive of pleural malignancy. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement. Patients with rate of fluid accumulation less than 30 days. Patient who signed informed consent about being involved in the study. Exclusion Criteria: Patients under the age of 18 years. Female patients who are Pregnant or nursing. Patients with rate of pleural effusion accumulation is more than 30 days. Patients who didn't show clinical improvement post proper draining of the fluid Patients who are hemodynamically or respiratory unstable. Patients with Empyema. Patients who are non functioning/ not active according to the Performance status. The type of malignancy which cause the malignant pleural effusion is Lymphoma. Patient who underwent pneumonectomy at the side of the fluid. previous pleurodesis at the side of pleural effusion. Chylothorax in the initial pleural tapping.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ran Kremer, MD
    Phone
    00972502063189
    Email
    r_kremer@rambam.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amit Katz, MD
    Phone
    00972502062291
    Email
    amit160275@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    18241636
    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. Erratum In: Mayo Clin Proc. 2009 Sep;84(9):847.
    Results Reference
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    PubMed Identifier
    20696691
    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.
    Results Reference
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    PubMed Identifier
    9272937
    Citation
    Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J. 1997 Aug;10(8):1907-13. doi: 10.1183/09031936.97.10081907.
    Results Reference
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    PubMed Identifier
    20544327
    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.
    Results Reference
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    PubMed Identifier
    930945
    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.
    Results Reference
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    PubMed Identifier
    11069845
    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.
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    PubMed Identifier
    24920947
    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.
    Results Reference
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    PubMed Identifier
    24102015
    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.
    Results Reference
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    PubMed Identifier
    19839739
    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.
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    PubMed Identifier
    21460729
    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.
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    PubMed Identifier
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    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.
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