Clinical trial: Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System (NCT03831386)

Eligibility criteria:
Inclusion Criteria:

          -  Clinical indications for placement of IPC for malignant pleural effusion

             a. Pleural effusion with symptomatic improvement in dyspnea after drainage of
             ipsilateral effusion

          -  Clinically confident symptomatic malignant pleural effusion

               1. Histocytological proof of pleural malignancy

               2. Recurrent large pleural effusion in context of histologically proven cancer
                  outside the pleural space

          -  Plans for placement of IPC within ten days of enrollment

          -  Age > 17 years

          -  Sufficient fluid on ultrasound to allow for safe insertion of IPC

        Exclusion Criteria:

          -  Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain

          -  Pregnant or lactating mothers

          -  Previous ipsilateral chemical pleurodesis

          -  Current contralateral indwelling pleural catheter

          -  Known rib or thoracic skeletal metastasis causing pain

          -  Concern for active pleural infection

          -  Respiratory failure

          -  Irreversible bleeding diathesis

          -  Inability to provide care for indwelling tunneled pleural catheter

          -  Significantly loculated pleural space precluding drainage of pleural space, for which
             IPC alone will likely not offer symptomatic benefit

          -  Estimated life expectancy of < 30 days (however, active enrollment in hospice program
             is not an exclusion criteria)

          -  Inability to read/understand/write in the English language

          -  Inability to follow-up for appointments/protocol

          -  Subject has any clinical condition, diagnosis, or social circumstance that, in the
             opinion of the investigator would mean participation in the study would be
             contraindicated.

          -  Enrollment in alternative pleural catheter trial that would preclude enrollment within
             this trial
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