Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

Study Overview
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Brief Summary
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The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

Detailed Description
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Malignant pleural effusion is a frequent complication in advanced neoplasia. Pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. However, the occurrence of severe adverse effects associated with its use has led to the search for other agents. Silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. Although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.

Official Title
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Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Drug: Silver Nitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy. Recurrent and symptomatic malignant pleural effusion. Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray. Karnofsky Performance Status >30 Agreement to participate of the study by signing of the Informed Consent Term. Exclusion Criteria: Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count). Active pleural or systemic infection. Massive skin neoplastic infiltration. Inability of understanding the pain scale. Previous pleural procedures (except for thoracocentesis and/or pleural biopsy). Refusal to participate of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silver Nitrate 1<br>Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution. | Drug: Silver Nitrate<br>* Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.<br>|
| Experimental: Silver Nitrate 2<br>Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter. | Drug: Silver Nitrate<br>* Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.<br>|
| Experimental: Silver Nitrate 3<br>Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter. | Drug: Silver Nitrate<br>* Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain on the first five days after pleurodesis | Chest pain will be evaluated via Visual Analog Scale. | Along the first five days after treatment | 
| Chest pain after 10 days of pleurodesis | Chest pain will be assessed using the Visual Analog Scale | On the 10th day after the procedure. | 
| Chest pain after 30 days of pleurodesis | Chest pain will be evaluated by Visual Analog Scale | Within 30 days of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the pleurodesis | On hospital discharge, five days after the procedure, patients are submitted to chest computerized tomography (CT). After 30 days of the procedure, patients are submitted to another chest CT and the volume of pleural effusion is calculated and compared to that of the hospital discharge date (calculated by the 5th day CT). | After 30 days of the procedure | 
| Dyspnea | Dyspnea will be evaluated through the British MRC dyspnea scale. | Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure. | 
| Adverse effects | The safety of the treatment will be assessed both by monitoring of complete blood counts, renal function, liver function and inflammation markers, as well as monitoring of body temperature, arterial blood pressure and heart rate. The occurrence of adverse side effects will be assessed using the United States National Cancer Institute Common Terminology Criteria for Adverse Events v.3.0. | Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleurodesis, Malignant pleural effusion, Silver Nitrate, Pain