NCT03831386 Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
| NCT ID | NCT03831386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Pleural Effusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-01-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2019-01-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 * 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 * Age \> 17 years * 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 * 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
Contact & Investigator
Lonny Yarmus, DO
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03831386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Effusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03831386 currently recruiting?
Yes, NCT03831386 is actively recruiting participants. Contact the research team at IPresearch@jhmi.edu for enrollment information.
Where is the NCT03831386 trial being conducted?
This trial is being conducted at Arlington Heights, United States, Baltimore, United States, Charleston, United States, Nashville, United States and 2 additional locations.
Who is sponsoring the NCT03831386 clinical trial?
NCT03831386 is sponsored by Johns Hopkins University. The principal investigator is Lonny Yarmus, DO at Johns Hopkins University. The trial plans to enroll 200 participants.