Pleural EffusionNCT05781659
The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
A study testing Ultrasound elastography guided pleural biopsy and Traditional ultrasound guided pleural biopsy in people with Pleural Effusion, run by China-Japan Friendship Hospital at 9 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Ultrasound elastography guided pleural biopsy and Traditional ultrasound guided pleural biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 9 sitesChina
- Study dates
- 7 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
- Sign the informed consent form
- The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation
Who cannot join
- The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.
- The pleural fluid cytology proved to be malignant.
- Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.
- Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
- Coagulation dysfunction.
- transudate
- The age is less than 18 years old.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000
Tong Run, MD
- Recruiting
the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Chen Yan, MD
- Recruiting
Gui Zhou Provincial People's Hospital
Guiyang, Guizhou, 550000
Ye Xianwei, MD
- Recruiting
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Xia Yang, MD
- Recruiting
Anhui Chest Hospital
Hefei, Anhui, 230000
Tang Fei, MM
- Recruiting
the First People's Hospital of Yunnan Provience
Kunming, Yunnan, 650000
Zhang Yunhui, MD
- Recruiting
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Xu Fei, MD
- Recruiting
the First Hospital of China Medical University
Shenyang, Liaoning, 110000
Ma Jiangwei, MD
- Recruiting
The Tenth People's Hospital of Shenyang
Shenyang, Liaoning, 110000
LI Chengjun, MM
About this study
The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.
Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.
- Conditions
- Pleural Effusion
- Being tested
- Ultrasound elastography guided pleural biopsy, Traditional ultrasound guided pleural biopsy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound elastography guided pleural biopsyProcedure or surgery
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Traditional ultrasound guided pleural biopsyProcedure or surgery
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound elastography guided pleural biopsy group | Experimental | Not described Receives: Procedure: Ultrasound elastography guided pleural biopsy |
| Traditional ultrasound-guided pleural biopsy group | Experimental | Not described Receives: Procedure: Traditional ultrasound guided pleural biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
The diagnosis would be confirmed according to the pathological results.
Measured: 7 days after the biopsy
Secondary outcomes (1)
Incidence rate of adverse events
Symptoms and signs
Measured: 7 days after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start7 Apr 2023
- Primary completion24 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781659
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0201-04
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deng M, Xia Y, Ye X, Ma J, Zhao S, Zhang Q, Li J, Lin J, Jing A, Li ZY, Jiang B, Wu J, Wen Q, Ma J, Tong R, Zheng Z, Xu W, Li X, Herth FJF, Hou G. Ultrasonic elastography-guided pleural biopsy versus traditional thoracic ultrasound-guided pleural biopsy for the diagnosis of pleural effusion: a multicentre, randomised trial. Eur Respir J. 2025 Dec 18;66(6):2501062. doi: 10.1183/13993003.01062-2025. Print 2025 Dec.
PubMed 40935584
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT05781659
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0201-04
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.
Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound elastography guided pleural biopsy group | Experimental | Procedure: Ultrasound elastography guided pleural biopsy |
| Traditional ultrasound-guided pleural biopsy group | Experimental | Procedure: Traditional ultrasound guided pleural biopsy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
- Sign the informed consent form
- The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation
Key exclusion criteria (7 listed)
- The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.
- The pleural fluid cytology proved to be malignant.
- Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.
- Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
- Coagulation dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound elastography guided pleural biopsyThe patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy. | Procedure or surgery | Ultrasound elastography guided pleural biopsy group |
| Traditional ultrasound guided pleural biopsyThe patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy. | Procedure or surgery | Traditional ultrasound-guided pleural biopsy group |
Primary outcome
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
Time frame: 7 days after the biopsy
The diagnosis would be confirmed according to the pathological results.
1 secondary outcome
Incidence rate of adverse events
Time frame: 7 days after the biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 40935584Deng M, Xia Y, Ye X, Ma J, Zhao S, Zhang Q, Li J, Lin J, Jing A, Li ZY, Jiang B, Wu J, Wen Q, Ma J, Tong R, Zheng Z, Xu W, Li X, Herth FJF, Hou G. Ultrasonic elastography-guided pleural biopsy versus traditional thoracic ultrasound-guided pleural biopsy for the diagnosis of pleural effusion: a multicentre, randomised trial. Eur Respir J. 2025 Dec 18;66(6):2501062. doi: 10.1183/13993003.01062-2025. Print 2025 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound elastography guided pleural biopsy and Traditional ultrasound guided pleural biopsy in people with Pleural Effusion, run by China-Japan Friendship Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion. (time frame: 7 days after the biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.