Clinical trial: Biomarker Levels During Indwelling Pleural cAtheter Sample Testing (NCT02092155)

Eligibility criteria:
Inclusion criteria:

          -  Pleural effusion (etiology fulfilling one of the following criteria):

               1. Malignant effusion confirmed by cytology or pleural biopsy

               2. exudative effusion in the setting of known malignancy with no other identifiable
                  cause

               3. Malignant effusion due to tumors that are historically rapidly responsive to
                  systemic therapy (small cell lung cancer, hematological malignancies) will only
                  be included if refractory to standard chemotherapy

          -  18 years of age

          -  Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort

          -  Demonstration of symptomatic improvement after therapeutic thoracentesis

          -  Recurrent pleural effusion after therapeutic thoracentesis

          -  Capacity to provide informed consent

        Exclusion criteria:

          -  Projected life expectancy less than 30 days.

          -  Radiographic evidence of trapped lung - persistent lung collapse with failure of the
             majority (>50%) of the lung to reexpand following drainage of a pleural effusion

          -  Previous lobectomy or pneumonectomy on the affected side

          -  Patient receiving intrapleural chemotherapy

          -  Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on
             lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct

          -  Parapneumonic effusion - pleural effusion associated with pneumonia

          -  Empyema - infected pleural space as defined by purulent pleural fluid, positive gram
             stain, or positive culture

          -  Inability to adequately perform pleural drainage at home

          -  Uncorrectable bleeding disorder

          -  Skin infection at the site of intended catheter insertion

          -  Pregnant women - detected by spot urine testing prior to the procedure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment