Rapid Pleurodesis Through an Indwelling Pleural Catheter

• Status: Terminated
• Trial end date: 2019-07-09
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania

Criteria

Inclusion Criteria:

1. Diagnosis of MPE as defined by

1. A diagnosis a pleural effusion in the setting of known malignancy. AND

2. Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR

3. Evidence of pleural disease on radiographic imaging. OR

4. A recurrent effusion with no other identifiable cause after thorough workup.

2. Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)

3. Prior thoracentesis with post procedure symptomatic relief

4. Recurrence of symptoms with re-accumulation of pleural effusion

5. Lung re-expansion after thoracentesis on chest imaging within last 30 days

Exclusion Criteria:

1. Malignant pleural effusion due to a hematologic malignancy

2. ECOG >4

3. Any history of trapped lung

4. Prior attempted pleurodesis on the affected site

5. Age <18

6. Pregnant or lactating

7. Known allergy to iodopovidone (Betadine)

8. Unable or unwilling to provide consent

9. Uncorrectable coagulopathy (INR > 1.5, aPTT > 1.5 x the upper limit of normal) or thrombocytopenia (< 50,000)

10. Anatomic contraindication to IPC (overlying skin abnormalities)

11. Unable or unwilling to care for IPC and adhere to drainage protocol

12. Need for bilateral IPC placement