<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03781908</url>
  </required_header>
  <id_info>
    <org_study_id>silver nitrate pleurodesis</org_study_id>
    <nct_id>NCT03781908</nct_id>
  </id_info>
  <brief_title>Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis</brief_title>
  <official_title>Management Of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to compare well-defined pleural effusion management success&#xD;
      outcomes in patients with malignant or paramalignant pleural effusions who were treated with&#xD;
      Indwelling pleural catheter insertion compared with those treated with siver nitrate&#xD;
      pleurodesis. It is also to demonstrate the effectiveness of silver nitrate pleurodesis. It is&#xD;
      also important to evaluate frequent adverse events of silver nitrate pleurodesis in patients&#xD;
      with malignant pleural effusion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dyspnea is present in 50% of patients with malignant pleural effusion and quality of life is&#xD;
      significantly impaired.&#xD;
&#xD;
      Chemical pleurodesis using various sclerosing agents is accepted as a palliative therapy for&#xD;
      patients with recurrent, symptomatic, and malignant pleural effusions.&#xD;
&#xD;
      Silver nitrate solution (SNS) is a valid sclerosing agent that induce a caustic injury to the&#xD;
      mesothelium that results in an effective pleurodesis.&#xD;
&#xD;
      However, various clinical parameters and biochemical factors affect the success of&#xD;
      pleurodesis in symptomatic patients with MPE: symptoms and performance status of the patient,&#xD;
      daily fluid drainage, primary tumour, and mainly lung reexpansion following pleural fluid&#xD;
      evacuation.&#xD;
&#xD;
      The pleural injectate consists of 50 mL 0.5% SNS with 10mL of lidocaine (25mg/5mL).&#xD;
&#xD;
      An alternative treatment is intermittent or continuous drainage of the pleural fluid with a&#xD;
      chronic indwelling pleural catheter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of silver nitrate pleurodesis</measure>
    <time_frame>One week</time_frame>
    <description>patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success rate of silver nitrate pleurodesis</measure>
    <time_frame>One month</time_frame>
    <description>Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chest pain: VAS</measure>
    <time_frame>One week</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>One week</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pleural Effusion, Malignant</condition>
  <arm_group>
    <arm_group_label>Silver Nitrate Pleurodesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indwelling Pleural Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Silver Nitrate</intervention_name>
    <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%.</description>
    <arm_group_label>Silver Nitrate Pleurodesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indwelling Pleural Catheter</intervention_name>
    <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 &quot;peel-away&quot; 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.</description>
    <arm_group_label>Indwelling Pleural Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the&#xD;
             criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a&#xD;
             Karnofsky index score of more than 60 and life expectancy of more than one year).&#xD;
&#xD;
          2. Rapidly accumulated undiagnosed pleural effusion .&#xD;
&#xD;
          3. Age : 30-75 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Transudative pleural effusion.&#xD;
&#xD;
          2. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic ,&#xD;
             post-tuberculous pleural effusion )&#xD;
&#xD;
          3. Presence of hemorrhagic diathesis ( prothrombin time &lt;50% and platelet count&#xD;
             &lt;80,000/mm 3 )&#xD;
&#xD;
          4. Active pleural or systemic infection.&#xD;
&#xD;
          5. Neoplastic infiltration of the skin at the site of pleural catheter insertion.&#xD;
&#xD;
          6. Malignant pleural effusion with trapped lung or loculated pleural effusion.&#xD;
&#xD;
          7. Previous lobectomy or pneumonectomy on the affected side.&#xD;
&#xD;
          8. Karnofsky index score&gt; 50.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Khaled Essmat, Master</last_name>
    <phone>+201003382727</phone>
    <email>khaledessmat@outlook.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammed Abdelghany, MD</last_name>
    <phone>+201006800525</phone>
    <email>mfawzy2013@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <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.</citation>
    <PMID>21790880</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20696691</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21651643</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24259053</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24273808</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24354096</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19169996</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9195549</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Khaled Essmat Hussien</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Silver Nitrate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781908
org study id: silver nitrate pleurodesis
nct id: NCT03781908
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Success rate of silver nitrate pleurodesis
time frame: One week
description: patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound .
measure: Success rate of silver nitrate pleurodesis
time frame: One month
description: Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound.
measure: Chest pain: VAS
time frame: One week
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
measure: Dyspnea
time frame: One week
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
arm group label: Silver Nitrate Pleurodesis
arm group type: Experimental
description: Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%
arm group label: Indwelling Pleural Catheter
arm group type: Active Comparator
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: Silver Nitrate
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%.
arm group label: Silver Nitrate Pleurodesis
intervention type: Device
intervention name: Indwelling Pleural Catheter
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.
arm group label: Indwelling Pleural Catheter
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Khaled Essmat, Master
phone: +201003382727
email: khaledessmat@outlook.com
last name: Mohammed Abdelghany, MD
phone: +201006800525
email: mfawzy2013@hotmail.com
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.
PMID: 21790880
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: 20696691
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.
PMID: 21651643
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.
PMID: 24259053
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.
PMID: 24273808
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.
PMID: 24354096
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.
PMID: 19169996
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.
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.
PMID: 9195549
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Khaled Essmat Hussien
investigator title: Principal Investigator
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion
mesh term: Silver Nitrate