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Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis

Primary Purpose

Pleural Effusion, Malignant

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Silver Nitrate
Indwelling Pleural Catheter
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion, Malignant

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a Karnofsky index score of more than 60 and life expectancy of more than one year).
  2. Rapidly accumulated undiagnosed pleural effusion .
  3. Age : 30-75 years old.

Exclusion Criteria:

  1. Transudative pleural effusion.
  2. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion )
  3. Presence of hemorrhagic diathesis ( prothrombin time <50% and platelet count <80,000/mm 3 )
  4. Active pleural or systemic infection.
  5. Neoplastic infiltration of the skin at the site of pleural catheter insertion.
  6. Malignant pleural effusion with trapped lung or loculated pleural effusion.
  7. Previous lobectomy or pneumonectomy on the affected side.
  8. Karnofsky index score> 50.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Silver Nitrate Pleurodesis

    Indwelling Pleural Catheter

    Arm Description

    Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%

    Catheters will be inserted in an outpatient setting under local anaesthesia.The typical drainage schedule is every other day using disposable plastic bottles (550 mL to 1 L)

    Outcomes

    Primary Outcome Measures

    Success rate of silver nitrate pleurodesis
    patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .
    Success rate of silver nitrate pleurodesis
    Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.

    Secondary Outcome Measures

    Chest pain: VAS
    Chest pain will be evaluated by visual analog scale which varies from (0-10) in which grade 0 indicates no hurt and grade 10 which hurts worst
    Dyspnea
    Dyspnea will be evaluated through the mMRC dyspnea scale ( modified medical research council dyspnea scale) which varies from ( 0-4) in which grade 0 indicates dyspnea with sternous exercise and grade 4 which indicates dyspnea with dressing or undressing

    Full Information

    First Posted
    November 11, 2018
    Last Updated
    December 19, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03781908
    Brief Title
    Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
    Official Title
    Management Of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    December 1, 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The primary goal of this study is to compare well-defined pleural effusion management success outcomes in patients with malignant or paramalignant pleural effusions who were treated with Indwelling pleural catheter insertion compared with those treated with siver nitrate pleurodesis. It is also to demonstrate the effectiveness of silver nitrate pleurodesis. It is also important to evaluate frequent adverse events of silver nitrate pleurodesis in patients with malignant pleural effusion
    Detailed Description
    Dyspnea is present in 50% of patients with malignant pleural effusion and quality of life is significantly impaired. Chemical pleurodesis using various sclerosing agents is accepted as a palliative therapy for patients with recurrent, symptomatic, and malignant pleural effusions. Silver nitrate solution (SNS) is a valid sclerosing agent that induce a caustic injury to the mesothelium that results in an effective pleurodesis. However, various clinical parameters and biochemical factors affect the success of pleurodesis in symptomatic patients with MPE: symptoms and performance status of the patient, daily fluid drainage, primary tumour, and mainly lung reexpansion following pleural fluid evacuation. The pleural injectate consists of 50 mL 0.5% SNS with 10mL of lidocaine (25mg/5mL). An alternative treatment is intermittent or continuous drainage of the pleural fluid with a chronic indwelling pleural catheter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Effusion, Malignant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Silver Nitrate Pleurodesis
    Arm Type
    Experimental
    Arm Description
    Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%
    Arm Title
    Indwelling Pleural Catheter
    Arm Type
    Active Comparator
    Arm Description
    Catheters will be inserted in an outpatient setting under local anaesthesia.The typical drainage schedule is every other day using disposable plastic bottles (550 mL to 1 L)
    Intervention Type
    Drug
    Intervention Name(s)
    Silver Nitrate
    Intervention Description
    First, pleural fluid drainage will be done after administration of 5 cc of local anesthetic lidocain1% either by insertion of chest tube (26F or 28F ) or by using ultrasonography. Pleural fluid drainage will be terminated when the patient want to cough to make sure that the pleural cavity is empty, then the sclerosant material will be injected, patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%.
    Intervention Type
    Device
    Intervention Name(s)
    Indwelling Pleural Catheter
    Intervention Description
    First , insert the wire into the pleural effusion at approximately the anterior axillary line. A 1-2 cm incision is made over the wire. A chest wall tunnel (5-8 cm in length) is created with a counter incision. The catheter is pulled through the tunnel and out next to the wire. After dilation of the wire tract with a Teflon "peel-away" sheath, the indwelling catheter is inserted into the chest. The counter incision is closed primarily, and the catheter is secured to the skin medially with a suture.
    Primary Outcome Measure Information:
    Title
    Success rate of silver nitrate pleurodesis
    Description
    patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .
    Time Frame
    One week
    Title
    Success rate of silver nitrate pleurodesis
    Description
    Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    Chest pain: VAS
    Description
    Chest pain will be evaluated by visual analog scale which varies from (0-10) in which grade 0 indicates no hurt and grade 10 which hurts worst
    Time Frame
    One week
    Title
    Dyspnea
    Description
    Dyspnea will be evaluated through the mMRC dyspnea scale ( modified medical research council dyspnea scale) which varies from ( 0-4) in which grade 0 indicates dyspnea with sternous exercise and grade 4 which indicates dyspnea with dressing or undressing
    Time Frame
    One week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a Karnofsky index score of more than 60 and life expectancy of more than one year). Rapidly accumulated undiagnosed pleural effusion . Age : 30-75 years old. Exclusion Criteria: Transudative pleural effusion. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion ) Presence of hemorrhagic diathesis ( prothrombin time <50% and platelet count <80,000/mm 3 ) Active pleural or systemic infection. Neoplastic infiltration of the skin at the site of pleural catheter insertion. Malignant pleural effusion with trapped lung or loculated pleural effusion. Previous lobectomy or pneumonectomy on the affected side. Karnofsky index score> 50.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Khaled Essmat, Master
    Phone
    +201003382727
    Email
    khaledessmat@outlook.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Abdelghany, MD
    Phone
    +201006800525
    Email
    mfawzy2013@hotmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21790880
    Citation
    Kalomenidis I. Beyond talc pleurodesis: do we really need new methods? Respirology. 2011 Oct;16(7):1020-2. doi: 10.1111/j.1440-1843.2011.02023.x. No abstract available.
    Results Reference
    background
    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
    background
    PubMed Identifier
    21651643
    Citation
    Tremblay A, Stather DR, Kelly MM. Effect of repeated administration of low-dose silver nitrate for pleurodesis in a rabbit model. Respirology. 2011 Oct;16(7):1070-5. doi: 10.1111/j.1440-1843.2011.02007.x.
    Results Reference
    background
    PubMed Identifier
    24259053
    Citation
    Shaw PH, Agarwal R. WITHDRAWN: Pleurodesis for malignant pleural effusions. Cochrane Database Syst Rev. 2013 Nov 20;(11):CD002916. doi: 10.1002/14651858.CD002916.pub3. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24273808
    Citation
    Arber A, Clackson C, Dargan S. Malignant pleural effusion in the palliative care setting. Int J Palliat Nurs. 2013 Jul;19(7):320, 322-5.
    Results Reference
    background
    PubMed Identifier
    24354096
    Citation
    Suarez PM, Gilart JL. Pleurodesis in the treatment of pneumothorax and pleural effusion. Monaldi Arch Chest Dis. 2013 Jun;79(2):81-6. doi: 10.4081/monaldi.2013.96.
    Results Reference
    background
    PubMed Identifier
    19169996
    Citation
    Schneider T, Reimer P, Storz K, Klopp M, Pfannschmidt J, Dienemann H, Hoffmann H. Recurrent pleural effusion: who benefits from a tunneled pleural catheter? Thorac Cardiovasc Surg. 2009 Feb;57(1):42-6. doi: 10.1055/s-2008-1039109. Epub 2009 Jan 23.
    Results Reference
    background
    Citation
    Ferlay JSH, Bray F, Forman D, Mathers C, Parkin DM, eds. Cancer incidence and mortality worldwide [webpage]. World Health Organization, International Agency for Research on Cancer; 2008. v1.2. CancerBase No. 10. http://globocan.iarc.fr. Accessed November 11, 2011.
    Results Reference
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    PubMed Identifier
    9195549
    Citation
    Light RW, Vargas FS. Pleural sclerosis for the treatment of pneumothorax and pleural effusion. Lung. 1997;175(4):213-23. doi: 10.1007/pl00007568.
    Results Reference
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    Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis

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