Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Recruiting now · Not applicable

Conditions studied: Pleural Effusion

In brief

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.

Key facts

Study ID

NCT03831386

Run by

Johns Hopkins University

People needed

200

Starts

2019-01-31

Expected to finish

2026-12-31

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Histocytological proof of pleural malignancy
• Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
• Plans for placement of IPC within ten days of enrollment
• Age > 17 years
• Sufficient fluid on ultrasound to allow for safe insertion of IPC

You may not qualify if…

• Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
• Pregnant or lactating mothers
• Previous ipsilateral chemical pleurodesis
• Current contralateral indwelling pleural catheter
• Known rib or thoracic skeletal metastasis causing pain
• Concern for active pleural infection
• Respiratory failure
• Irreversible bleeding diathesis
• 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
• 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 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.
• Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial

Where it is running

• Northwest Community Healthcare — Arlington Heights, Illinois, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• University of Oxford — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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