Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

Qualifiers

Clinical indications for placement of IPC for malignant pleural 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vacuum-Based IPC
  • Gravity-Based IPC

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

Rocket Medical plc

Collaborator

Swedish Medical Center

Collaborator

Medical University of South Carolina

Collaborator

University of Oxford

Collaborator

Vanderbilt University Medical Center

Collaborator

Northwest Community Healthcare

Collaborator