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Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.
Lung
N/A
Adults
Not Available
Not Available
Maldonado, Fabien
National
Vanderbilt University
09-27-2018
Treatment
VICCTHO19118
NCT03831386

Eligibility

18 Years and older
ALL
false
Inclusion Criteria:

Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion

Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion

Clinically confident symptomatic malignant pleural effusion 1. Histocytological proof of pleural malignancy 2. Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space

Clinically confident symptomatic malignant pleural effusion 1. Histocytological proof of pleural malignancy 2. Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space

Plans for placement of IPC within ten days of enrollment

Plans for placement of IPC within ten days of enrollment

Age > 17 years

Age > 17 years

Sufficient fluid on ultrasound to allow for safe insertion of IPC

Sufficient fluid on ultrasound to allow for safe insertion of IPC



Exclusion Criteria:

Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain

Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain

Pregnant or lactating mothers

Pregnant or lactating mothers

Previous ipsilateral chemical pleurodesis

Previous ipsilateral chemical pleurodesis

Current contralateral indwelling pleural catheter

Current contralateral indwelling pleural catheter

Known rib or thoracic skeletal metastasis causing pain

Known rib or thoracic skeletal metastasis causing pain

Concern for active pleural infection

Concern for active pleural infection

Respiratory failure

Respiratory failure

Irreversible bleeding diathesis

Irreversible bleeding diathesis

Inability to provide care for indwelling tunneled pleural catheter

Inability to provide care for indwelling tunneled pleural catheter

Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit

Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit

Estimated life expectancy of 30 days (however, active enrollment in hospice program is not an exclusion criteria)

Estimated life expectancy of 30 days (however, active enrollment in hospice program is not an exclusion criteria)

Inability to read/understand/write in the English language

Inability to read/understand/write in the English language

Inability to follow-up for appointments/protocol

Inability to follow-up for appointments/protocol

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

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

Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial

Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial

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