Clinical trial: A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions (NCT02227732)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is ≥ 18 years old.

          2. 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 histocytological confirmation of pleural malignancy

               -  The effusion is an exudate (as per Light's criteria) in the context of
                  histocytologically proven malignancy elsewhere, with no other clear cause for
                  fluid identified

          3. Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea
             that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.

          4. Subject is willing and able to provide written informed consent.

          5. Subject is willing and able to meet all study requirements, including attending
             follow-up visits or receiving trial-related telephone calls.

          6. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an
             indwelling pleural catheter

          7. Negative pregnancy test if appropriate

        Exclusion Criteria:

          1. Subject has significant trapped lung (>20%), or a proximal bronchial obstruction which
             is likely to lead to trapped lung.

          2. Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3*
             or more.

          3. Subject is pregnant, planning to become pregnant, or is lactating.

          4. Subject has a history of empyema.

          5. Subject has a history of chylothorax.

          6. Subject has an uncorrected coagulopathy.

          7. Subject is allergic to device materials.

          8. Subject has evidence, in the opinion of the Chief Investigator, of either on-going
             systemic or pleural infection.

          9. Subject has had a lobectomy or pneumonectomy on the side of the effusion.

         10. Subject has undergone a previous attempt at pleurodesis which has failed.

         11. Subject has previously been diagnosed with a serious immunodeficiency disorder.

         12. Subject has bilateral pleural effusions, with both being at least moderate in size
             (greater than 1/3 of the hemithorax on chest x-ray).

         13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely
             to be futile.

         14. Subject has a mediastinal shift of ≥2cm toward the side of the effusion.

         15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the
             ipsilateral chest.

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

         17. Subject has no access to a telephone

         18. No details of blood values (full blood count, clotting screen, urea and electrolytes,
             liver function) from within the last 10 days * Patients who have a performance status
             of 3 may be considered for the trial if the removal of their fluid would likely
             improve their performance score by 1 or more.
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