Status:
TERMINATED
Rapid Pleurodesis Through an Indwelling Pleural Catheter
Lead Sponsor:
University of Pennsylvania
Conditions:
Pleural Effusion, Malignant
Pleurodesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 remo...
Detailed Description
Patients will be screened throughout the year as part of the clinical referral process to the Interventional Pulmonology service at the Hospital of the University of Pennsylvania for the management of...
Eligibility Criteria
Inclusion
- Diagnosis of MPE as defined by
- A diagnosis a pleural effusion in the setting of known malignancy. AND
- Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
- Evidence of pleural disease on radiographic imaging. OR
- A recurrent effusion with no other identifiable cause after thorough workup.
- Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
- Prior thoracentesis with post procedure symptomatic relief
- Recurrence of symptoms with re-accumulation of pleural effusion
- Lung re-expansion after thoracentesis on chest imaging within last 30 days
Exclusion
- Malignant pleural effusion due to a hematologic malignancy
- ECOG \>4
- Any history of trapped lung
- Prior attempted pleurodesis on the affected site
- Age \<18
- Pregnant or lactating
- Known allergy to iodopovidone (Betadine)
- Unable or unwilling to provide consent
- Uncorrectable coagulopathy (INR \> 1.5, aPTT \> 1.5 x the upper limit of normal) or thrombocytopenia (\< 50,000)
- Anatomic contraindication to IPC (overlying skin abnormalities)
- Unable or unwilling to care for IPC and adhere to drainage protocol
- Need for bilateral IPC placement
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03325192
Start Date
December 12 2017
End Date
July 9 2019
Last Update
May 8 2020
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104