A Phase 2 interventional study of Silver Nitrate in Malignant Pleural Effusion, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-05-18.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
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.
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.
154 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's planned enrollment of 60 is close to the median of 57 across 112 interventional studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.
Drug: Silver Nitrate
Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.
Drug: Silver Nitrate
Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.
Drug: Silver Nitrate
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.
Chest pain on the first five days after pleurodesis
Chest pain will be evaluated via Visual Analog Scale.
Time frame: Along the first five days after treatment
Chest pain after 10 days of pleurodesis
Chest pain will be assessed using the Visual Analog Scale
Time frame: On the 10th day after the procedure.
Chest pain after 30 days of pleurodesis
Chest pain will be evaluated by Visual Analog Scale
Time frame: Within 30 days of the procedure
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).
Time frame: After 30 days of the procedure
Dyspnea
Dyspnea will be evaluated through the British MRC dyspnea scale.
Time frame: 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.
Time frame: Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure
This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital