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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver Nitrate Pleurodesis | Experimental | Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1% |
|
| Indwelling Pleural Catheter | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Nitrate | Drug | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of silver nitrate pleurodesis | patients will be submitted to serial chest x-ray and evaluation of pleural fluid accumulation by chest ultrasound . | One week |
| Success rate of silver nitrate pleurodesis | Pleural fluid re-accumulation will be evaluated by chest x-ray and chest ultrasound. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khaled Essmat, Master | Contact | +201003382727 | khaledessmat@outlook.com | |
| Mohammed Abdelghany, MD | Contact | +201006800525 | mfawzy2013@hotmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21790880 | Background | 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. | |
| 20696691 | Background | 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. |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D012835 | Silver Nitrate |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D017942 | Nitric Acid |
| D017672 | Nitrogen Compounds |
| D007287 | Inorganic Chemicals |
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|
| Indwelling Pleural Catheter | Device | 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. |
|
| One week |
| 21651643 | Background | 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. |
| 24259053 | Background | Shaw PH, Agarwal R. WITHDRAWN: Pleurodesis for malignant pleural effusions. Cochrane Database Syst Rev. 2013 Nov 20;2013(11):CD002916. doi: 10.1002/14651858.CD002916.pub3. |
| 24273808 | Background | 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. |
| 24354096 | Background | 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. |
| 19169996 | Background | 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. |
| Background | 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. |
| 9195549 | Background | Light RW, Vargas FS. Pleural sclerosis for the treatment of pneumothorax and pleural effusion. Lung. 1997;175(4):213-23. doi: 10.1007/pl00007568. |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D018030 |
| Silver Compounds |