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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Management Of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis

Conditions
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Pleural Effusion, Malignant

Intervention / Treatment
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* Drug: Silver Nitrate
* Device: Indwelling Pleural Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver Nitrate Pleurodesis<br>Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1% | Drug: Silver Nitrate<br>* 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%.<br>|
| Active Comparator: Indwelling Pleural Catheter<br>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) | Device: Indwelling Pleural Catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | One week |