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New ultrasound method could replace invasive lung biopsy for fluid diagnosis

NCT ID NCT07419620

Diagnosis Sponsor: China-Japan Friendship Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether starting with a less invasive ultrasound-guided biopsy can match the accuracy of immediate thoracoscopy (a camera-guided biopsy) for diagnosing unexplained fluid around the lungs. 420 adults with this condition will be randomly assigned to either the step-up approach or immediate thoracoscopy. The goal is to see if the step-up method is just as good at finding the cause, while being safer and cheaper.

What this could mean

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

Active substance
Ultrasound elastography-guided pleural biopsy and semi-rigid medical thoracoscopic pleural biopsy
What this could lead to
If successful, this could offer a less invasive, safer, and more cost-effective way to diagnose pleural effusion, potentially reducing the need for thoracoscopy.
What could go wrong
This is an early-stage trial with no results yet. The step-up approach may not be as accurate as immediate thoracoscopy, and some patients may still need the more invasive procedure.

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 420 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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: 1. Age ≥18 years; 2. Patients with exudative pleural effusion of unknown origin; 3. Patients with negative pleural fluid cytology results; 4. Patients who had not undergone pleural biopsy before enrolment. Exclusion Criteria: 1. Significantly bleeding risk, including uncorrectable coagulopathy (such as INR \>1.5, platelet count \<50×109 /L) or the need for ongoing anticoagulant/antiplatelet therapy that cannot be safely paused; 2. Hemodynamic instability; 3. Refractory hypoxemia despite supplemental oxygen; 4. Any severe concurrent illness or cardiopulmonary compromise that, in the investigator's judgment, makes either procedural sedation (for thoracoscopy) or a bedside biopsy (for UEPB) unsafe; 5. Pleural effusion conclusively identified as a transudate; 6. Pregnancy or lactation; 7. Any condition that, in the investigator's judgment, would compromise protocol compliance or follow-up.

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Conditions

The condition(s) this trial relates to.

pleural disorder Pleural Effusion

As listed by the trial registrant

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

Pleural effusion disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.