Clinical trial: EDIT Management Feasibility Trial (NCT03319186)

Eligibility criteria:
Inclusion Criteria:

          -  Clinically confident diagnosis of malignant pleural effusion, defined as any of the
             following:

               1. Pleural effusion with histocytologically proven pleural malignancy OR

               2. Pleural effusion in the context of histocytologically proven malignancy
                  elsewhere, without a clear alternative cause for fluid OR

               3. Pleural effusion with typical features of malignancy with pleural involvement on
                  cross-sectional imaging (CT/MRI)

          -  Degree of breathlessness for which therapeutic pleural intervention would be offered

          -  Age >18 years

          -  Expected survival > 3 months

          -  Written Informed Consent

        Exclusion Criteria:

          -  Females who are pregnant or lactating

          -  Clinical suspicion of non-expansile lung for which talc pleurodesis would not be
             offered

          -  Patient preference for 1st-line indwelling pleural catheter (IPC) insertion

          -  Previous ipsilateral failed talc pleurodesis

          -  Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound

          -  Any contraindication to chest drain or IPC insertion, including:

        Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC
        tunnel site

        - Any contraindication to MRI scanning, including:

        Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign
        body Previously documented reaction to Gadolinium-containing intravenous contrast agent
        Significant renal impairment (eGFR<30 ml/min)
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