Clinical trial: Rapid Pleurodesis Through an Indwelling Pleural Catheter (NCT03325192)

Eligibility criteria:
Inclusion Criteria:

          1. Diagnosis of MPE as defined by

               1. A diagnosis a pleural effusion in the setting of known malignancy. AND

               2. Confirmed malignant involvement of the pleural space by fluid cytology or pleural
                  biopsy. OR

               3. Evidence of pleural disease on radiographic imaging. OR

               4. A recurrent effusion with no other identifiable cause after thorough workup.

          2. Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)

          3. Prior thoracentesis with post procedure symptomatic relief

          4. Recurrence of symptoms with re-accumulation of pleural effusion

          5. Lung re-expansion after thoracentesis on chest imaging within last 30 days

        Exclusion Criteria:

          1. Malignant pleural effusion due to a hematologic malignancy

          2. ECOG >4

          3. Any history of trapped lung

          4. Prior attempted pleurodesis on the affected site

          5. Age <18

          6. Pregnant or lactating

          7. Known allergy to iodopovidone (Betadine)

          8. Unable or unwilling to provide consent

          9. Uncorrectable coagulopathy (INR > 1.5, aPTT > 1.5 x the upper limit of normal) or
             thrombocytopenia (< 50,000)

         10. Anatomic contraindication to IPC (overlying skin abnormalities)

         11. Unable or unwilling to care for IPC and adhere to drainage protocol

         12. Need for bilateral IPC placement
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