Clinical trial: A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions (NCT00758316)

Eligibility criteria:
Inclusion criteria:

          1. Patients aged ≥ 18 with suspected or known symptomatic malignant pleural effusions
             (i.e. age >60 or smoking history > 20 pack years or moderate effusion >1/3 hemithorax)

          2. Ability and willingness to sign informed consent. See Annex 1 for patient information
             sheet and informed consent form.

          3. Absence of contraindications to thoracoscopy and tunnelled pleural catheters

          4. Willingness to comply with follow-up i.e. outpatient follow-up at 1 week and at 1
             month for standard intervention; and additional every other day drainage in the
             intervention group (up to 5 times).

        Exclusion criteria:

          1. Uncorrected coagulopathy with platelet count ≤ 60 and INR ≥ 1.5.

          2. Uncontrolled coughing because of risk of lung puncture and air leaks

          3. Severe hypoxemia with a PaO2/FiO2 ratio ≤ 200 or hypercapnia with a PaCO2 ≥ 60 mmHg.

          4. Unstable cardiovascular status ie. hemodynamic instability requiring
             inotropes/vasopressors, recent myocardial infarction < 5 days or uncontrolled
             arrythmias

          5. Uncontrolled psychiatric disorders or absence of a significant caregiver both of which
             will contraindicate sending the patient home with a tunnelled catheter

          6. Previous thoracic surgery/intervention to the affected hemothorax which may have
             obliterated the pleural space

          7. Local skin infections that prevent long term catheter placement

          8. Morbid obesity which will increase risks associated with moderate sedation in the
             endoscopy centre

          9. Multi-loculated effusions that will not benefit from drainage

         10. Suspected pregnancy
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.


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? 1