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
About this trial
This is an interventional treatment trial for Pleural Effusion, Malignant
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.
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
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
background
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
background
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Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
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