Clinical trial: Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System (NCT03414905)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female, at least 18 years of age, inclusive

          -  Subject has a symptomatic malignant pleural effusion requiring intervention. For an
             effusion to be defined as malignant, at least one of the following must be true

               -  There is cytological confirmation of pleural malignancy

               -  The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum
                  protein >0.5, Pleural fluid LDH/Serum LDH >0.6, or Pleural fluid LDH >2/3 the
                  upper limit of normal) in the context of histocytologically proven malignancy
                  elsewhere, with no other clear cause for fluid identified

          -  Subject is able to provide informed consent

          -  Subject is willing and able to meet study requirements, including follow up visits

          -  Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled
             pleural catheter as determined by the PI

          -  Subject is able to perform home drainage of the pleural effusion or has sufficient
             resources (family member, caregiver, home health).

        Exclusion Criteria:

          -  Patients who refuse to participate

          -  Are less than 18 years of age

          -  Are pregnant

          -  Are unable to provide informed consent

          -  Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural
             infection

          -  Subjects with uncorrected coagulopathy

          -  All patients whom do not have malignant pleural effusions as outlined in the
             "definitions" section
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? Entailment