Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Pulmonary |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | July 9, 2018 |
| End Date: | May 31, 2020 |
| Contact: | Alexander Chen, M.D. |
| Email: | chenac@wustl.edu |
| Phone: | 314-454-8764 |
Indwelling tunneled pleural catheters have been successfully used to palliate dyspnea
associated with recurrent malignant pleural effusions with few complications and spontaneous
pleurodesis occurring in 30-50% of patients when using vacuum assisted drainage systems.
Notably, all data on palliation of dyspnea as well as on rates of spontaneous pleurodesis
have been performed using indwelling tunneled pleural catheters with vacuum assisted drainage
systems. No current data exists regarding the efficacy, complications or rate of spontaneous
pleurodesis when using indwelling tunneled pleural catheters and non-vacuum assisted drainage
systems. This study is designed to evaluate an indwelling tunneled pleural catheter with a
non-vacuum assisted drainage system for the management of recurrent malignant pleural
effusions.
associated with recurrent malignant pleural effusions with few complications and spontaneous
pleurodesis occurring in 30-50% of patients when using vacuum assisted drainage systems.
Notably, all data on palliation of dyspnea as well as on rates of spontaneous pleurodesis
have been performed using indwelling tunneled pleural catheters with vacuum assisted drainage
systems. No current data exists regarding the efficacy, complications or rate of spontaneous
pleurodesis when using indwelling tunneled pleural catheters and non-vacuum assisted drainage
systems. This study is designed to evaluate an indwelling tunneled pleural catheter with a
non-vacuum assisted drainage system for the management of recurrent malignant pleural
effusions.
Inclusion Criteria:
- Male or female, at least 18 years of age, inclusive
- 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 cytological confirmation of pleural malignancy
- 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
- Subject is able to provide informed consent
- Subject is willing and able to meet study requirements, including follow up visits
- Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled
pleural catheter as determined by the PI
- Subject is able to perform home drainage of the pleural effusion or has sufficient
resources (family member, caregiver, home health).
Exclusion Criteria:
- Patients who refuse to participate
- Are less than 18 years of age
- Are pregnant
- Are unable to provide informed consent
- Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural
infection
- Subjects with uncorrected coagulopathy
- All patients whom do not have malignant pleural effusions as outlined in the
"definitions" section
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Alexander Chen, M.D.
Phone: 314-454-8764
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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