Back to search results

Comparing Drainage Methods for Malignant Pleural Effusion

This study is for people with malignant pleural effusion (fluid around the lungs caused by cancer) who need an indwelling tunneled pleural catheter (IPC) to drain the fluid. It compares two ways of draining fluid: Vacuum-Based IPC, which uses suction, and Gravity-Based IPC, which drains by gravity. Researchers want to see if one method causes less chest pain and improves quality of life more than the other. You can join if you are 18 or older and have a confirmed malignant pleural effusion that improves after fluid drainage. The main goal is to measure changes in chest pain daily for up to two weeks. The study is currently recruiting about 200 participants.

Study design
This is an interventional study that plans to enroll 200 participants. Participants will be randomly assigned to either the Vacuum-Based IPC or Gravity-Based IPC group.
What's involved
You will have an IPC placed and then follow either a suction or gravity drainage strategy. You will fill out quality of life questionnaires and update a drainage diary.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up visits at two weeks, four weeks, twelve weeks, and then as needed after your IPC is placed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03831386

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~200 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Vacuum-Based IPCGravity-Based IPC

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in chest pain as assessed by Visual Analog Scale (VAS)
Measured over Daily, up to 2 weeks

Conditions

Pleural Effusion

Explore related trials

Pleural Effusion

Where it's being run

6 sites across 6 states
Illinois1
Maryland1
South Carolina1
Tennessee1
Washington1
United Kingdom1

Study leadership

  • Lonny Yarmus, DO · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Clinical indications for placement of IPC for malignant pleural effusion
Clinically confident symptomatic malignant pleural effusion
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

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
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

What this trial measures

  • Change in chest pain as assessed by Visual Analog Scale (VAS)Daily, up to 2 weeks

    The primary endpoint is the difference between the mean daily change in pain score during IPC drainage via the vacuum bottle technique and IPC drainage via the gravity bag technique over two weeks after IPC placement. Pre-drainage and post-drainage pain scores will be recorded each day of IPC placement. Measurements are in millimeters along a 10 cm VAS. VAS score is a range of 0 to 100. Lower limit is 0, meaning no pain; upper limit is 100, meaning extreme pain.