Clinical trial NCT03831386: Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Official title: The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Rocket Medical plc
name: Swedish Medical Center
name: Medical University of South Carolina
name: University of Oxford
name: Vanderbilt University Medical Center
name: Northwest Community Healthcare
First posted: 2019-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Indwelling tunneled pleural catheters (IPCs) are used to alleviate pleural effusion as a first-line therapeutic (albeit palliative) intervention. Limited data currently exists on drainage techniques and the impact the techniques may have on quality of life. Current recommendations for IPC drainage range from daily drainage to once a week drainage, as well as only when needed for dyspnea. It has been theorized that active drainage of effusions may have an impact on the development of chest discomfort/pain, whereas passive regimens may allow for more gradual intrathoracic pleural changes and potentially offer a difference in drainage discomfort.

The objective of this investigation is to compare different drainage strategies of indwelling pleural catheters (IPCs) regarding patient quality of life and outcomes. Patients will undergo placement of a pleural catheter as per standard institutional protocol. Patients will be randomized on a 1:1 basis into the suction drainage (active) arm or the gravity drainage (passive) arm. Patients will receive follow-up at two weeks, four weeks, twelve weeks and then as needed post IPC placement per standard clinical protocol. All patients will be asked to fill out quality of life questionnaires and update drainage diary information with patient's providers.

Patients will undergo standard care treatment throughout the disease course and no different interventions regarding the pleural disease will be performed as a result of enrollment within this study. Study interventions/procedures will consist of questionnaires and patient self-reported documentation regarding patient's care 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

Primary outcomes:
measure: Change in chest pain as assessed by Visual Analog Scale (VAS)
timeFrame: Daily, up to 2 weeks
Secondary outcomes:
measure: Change in mean difference in chest pain as assessed by VAS
timeFrame: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
measure: Change in SF 36-Item Health Survey score
timeFrame: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score
timeFrame: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Northwest Community Healthcare
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: Johns Hopkins University
name: Lonny Yarmus, DO
role: PRINCIPAL_INVESTIGATOR
References: