Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion
Condition: Malignant Pleural Effusion
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Intervention: Talc
Intervention description: All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the experiences of subjects who drain malignant
      (cancerous) pleural effusions (fluid) from around their lung(s) in a more frequent manner
      using a talc instilled via tunneled pleural catheter combined with daily drainage and those
      subjects who drain this fluid in a daily standard manner.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, at least 18 years of age, inclusive.

          2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as
             malignant, at least one of the following must be true:

               1. There is histocytological confirmation of pleural malignancy

               2. The effusion is an exudate (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 1 ipsilateral pleural effusion causing dyspnea that
             responded to thoracentesis where the lung expanded and the dyspnea was improved.

          4. Subject is willing and able to provide written informed consent.

          5. Subject is willing and able to meet all study requirements, including follow-up visits
             and receiving study-related telephone calls.

          6. Subject has sufficient pleural fluid to allow safe insertion of an IPC.

          7. Subject has negative pregnancy test if appropriate.

          8. Subject or caregiver is able to perform home drainage of the pleural effusion (a
             caregiver can be a friend, family member, or paid healthcare professional).

        Exclusion Criteria:

          1. Subject has significant trapped lung, or a proximal bronchial obstruction which is
             likely to lead to trapped lung. For a subject to be eligible for this study, two
             separate study center clinicians must agree that there is no significant trapped lung
             on the same CXR using visual estimation (reference guide). The CXR used to make this
             decision must have been performed ≤30 days preceding the consent form being signed,
             and must have been performed preferably on the same day, but no more than 7 calendar
             days after tunneled pleural catheter insertion. Significant trapped lung is deemed
             present if any 1 of the following criteria is met:

               1. A CXR shows hydropneumothorax other than small (< 1 cm between chest wall and
                  pleural line) apical pneumothoraces.

               2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung
                  parenchymal markings and there is no suggestion of pleural fluid.

               3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid
                  AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung
                  (e.g., chest pain or cough).

          2. Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern
             Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a
             performance status of 3 may be considered for the study if the removal of their fluid
             would likely improve their performance score by 1 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.