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Which drainage method hurts less? new trial aims to ease pain for lung fluid patients

NCT ID NCT03831386

Symptom relief Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study compares two ways of draining fluid from around the lungs in people with advanced cancer: one using suction (vacuum) and one using gravity. The goal is to see which method causes less chest pain during drainage. About 200 participants will be randomly assigned to one of the two methods, and their pain levels will be tracked over two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
indwelling pleural catheter (IPC) drainage system
What this could lead to
If this trial succeeds, it could identify a less painful way to drain fluid from around the lungs, improving daily comfort for people with advanced cancer.
What could go wrong
This is a relatively small, early-stage study focused on symptom relief, not a cure. The results may not apply to all patients, and the benefit might be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pleural Effusion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pleural effusion

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Northwest Community Healthcare

    Arlington Heights, Illinois, 60005, United States

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • University of Oxford

    Oxford, United Kingdom

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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