Clinical trial: Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter (NCT00978939)

Eligibility criteria:
Inclusion Criteria:

          1. Age greater than 18 years old

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

               -  Malignant effusion confirmed by cytology or pleural biopsy

               -  Exudative effusion in the setting of known malignancy with no other identifiable
                  cause

               -  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

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

          4. Age greater than 18 years old

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

               -  Demonstration of symptomatic improvement after therapeutic thoracentesis (removal
                  of ≤ 1.5 L of pleural fluid)

               -  Recurrent pleural effusion after therapeutic thoracentesis

        Exclusion Criteria:

          1. Projected life expectancy less than 30 days as predicted by Karnofsky Performance
             Status score less than 30

          2. Radiographic evidence of trapped lung - persistent lung collapse with failure of the
             lung to reexpand following drainage of a pleural effusion

          3. Radiographic evidence of loculated pleural fluid

          4. Previous attempted pleurodesis on the affected side

          5. Previous lobectomy or pneumonectomy on the affected side

          6. Patient receiving intrapleural chemotherapy

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

          8. Parapneumonic effusion - pleural effusion associated with pneumonia

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

         10. Inability to adequately perform pleural drainage at home

         11. Uncorrectable bleeding disorder

         12. Skin infection at the site of intended catheter insertion

         13. Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.


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