Pleural Effusion DisorderNCT07114783
Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease
A study testing Dual-function semi-rigid thoracoscopy and Rigid thoracoscopy in people with Pleural Effusion Disorder, run by China-Japan Friendship Hospital.
Trial summary
Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion Disorder
- What is being tested?
- Dual-function semi-rigid thoracoscopy and Rigid thoracoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Who cannot join
- Patients with PaO2/FiO2 <300;
- Patients with a tendency for uncontrolled bleeding, unstable cardiovascular status or severe heart failure;
- Patients with complete pleural symphysis, where it was not possible to create a pneumothorax, were excluded subsequently;
- Patients with refractory cough;
- Patients with Eastern Cooperative Oncology Group performance status 4;
- Patients did not agree to participate in this study;
- Participation in other studies within three months without withdrawal or termination will affect the observation of this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease: a Randomised Controlled Trial
Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained.
Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists.
To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.
- Conditions
- Pleural Effusion Disorder
- Being tested
- Dual-function semi-rigid thoracoscopy, Rigid thoracoscopy
- Keywords
- Medical Thoracoscopy, Pleural Disease
- Medical subject headings
- Pleural Effusion, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-function semi-rigid thoracoscopyDevice
Patients received pleural biopsy via dual-function semi-rigid thoracoscopy.
Rigid thoracoscopyDevice
Patients received pleural biopsy via rigid thoracoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Dual-function Semi-rigid Thoracoscopy | Experimental | Not described Receives: Device: Dual-function semi-rigid thoracoscopy |
| Rigid Thoracoscopy | Other | Not described Receives: Device: Rigid thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.
Measured: 7 days after the procedure.
Secondary outcomes (7)
Procedural Sedative and Analgesic Requirements
Procedural sedative and analgesic requirements will be assessed by recording the total dose of each sedative or analgesic agent administered during thoracoscopy, including midazolam, pentazocine, and tramadol. The dose of each agent will be recorded separately in milligrams and summarised by treatment group
Measured: The day of thoracoscopy.
Disease-specific Diagnostic Sensitivity
Disease-specific diagnostic sensitivity is defined as the percentage of participants with a specific final diagnosis according to the reference standard whose allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis supporting the same disease. Participants with non-specific biopsy findings who are subsequently diagnosed with malignant pleural disease or tuberculous pleuritis during follow-up will be classified as false-negative biopsy results for the corresponding disease.
Measured: Up to 12 months after thoracoscopy.
Sampling Quality of Pleural Biopsy Specimens
Sampling quality will be assessed using specimen size, specimen depth, and specimen interpretability. Specimen size will be measured as the largest cross-sectional area of the processed biopsy specimens on microscopic glass slides using ImageJ software and reported in square millimetres. Specimen depth will be assessed according to the presence of thoracic wall fatty tissue. Specimen interpretability will be classified as easily interpretable, interpretable with some difficulty, interpretable with great difficulty, or non-interpretable.
Measured: Up to 4 weeks after thoracoscopy.
Procedure Duration
Procedure duration will be measured in minutes from skin incision to completion of chest tube placement and wound closure.
Measured: The day of thoracoscopy.
Operator-assessed Device Performance
Operator-assessed device performance will include image quality, ease of manoeuvring, ease of obtaining a biopsy sample, and the operator's expectation that the biopsy sample will provide a definitive histological diagnosis. Each domain will be assessed immediately after the procedure using a visual analogue scale ranging from 0 to 100, with higher scores indicating better operator-assessed performance.
Measured: Immediately after the thoracoscopic procedure
Post-thoracoscopy Pain Score
Patient-reported post-thoracoscopy pain will be assessed using a 100-mm visual analogue scale while at rest and while coughing. Scores range from 0 to 100, with higher scores indicating more severe pain.
Measured: At 2, 6, 12, 24, and 48 hours after thoracoscopy
Procedure-related Complications
Procedure-related complications will be classified as major or minor complications. Major complications include empyema, major haemorrhage defined as a drop in haemoglobin of at least 1 g/dL or requiring blood transfusion, persistent air leak for more than 3 days, and re-expansion pulmonary oedema. Minor complications include subcutaneous emphysema, operative site infection, non-infective fever, and minor haemorrhage.
Measured: At discharge from the index hospitalization, up to 30 days after thoracoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 Effusion DisorderStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 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
- NCT07114783
- Sponsor's protocol ID
- 2025-UE-2
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the main publication will be made available upon reasonable request. The shared data will include baseline characteristics, allocated intervention, primary and secondary outcome data, and procedure-related complication data.
Publications
Xu L, Liu X, Wu H, Xie Z, Wang K, Deng M, Zheng Z, Hou G. Diagnostic yield and safety of Dual-functIon Semi-rigid thoraCoscOpy Versus rigid thoracoscopy for the diagnosis of plEuRal disease (DISCOVER-2): protocol for a randomised controlled trial. BMJ Open. 2026 Jul 8;16(7):e118022. doi: 10.1136/bmjopen-2026-118022.
PubMed 42419899
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07114783
- Acronym / sponsor ID
- 2025-UE-2
- Conditions
- Pleural Effusion Disorder
- Keywords
- Medical Thoracoscopy, Pleural Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (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.
Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained.
Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists.
To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-function Semi-rigid Thoracoscopy | Experimental | Device: Dual-function semi-rigid thoracoscopy |
| Rigid Thoracoscopy | Other | Device: Rigid thoracoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
- Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Key exclusion criteria (7 listed)
- Patients with PaO2/FiO2 <300;
- Patients with a tendency for uncontrolled bleeding, unstable cardiovascular status or severe heart failure;
- Patients with complete pleural symphysis, where it was not possible to create a pneumothorax, were excluded subsequently;
- Patients with refractory cough;
- Patients with Eastern Cooperative Oncology Group performance status 4;
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 |
|---|---|---|
| Dual-function semi-rigid thoracoscopyPatients received pleural biopsy via dual-function semi-rigid thoracoscopy. | Device | Dual-function Semi-rigid Thoracoscopy |
| Rigid thoracoscopyPatients received pleural biopsy via rigid thoracoscopy. | Device | Rigid Thoracoscopy |
Primary outcome
Diagnostic yield
Time frame: 7 days after the procedure.
Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.
7 secondary outcomes
Procedural Sedative and Analgesic Requirements
Time frame: The day of thoracoscopy.
Disease-specific Diagnostic Sensitivity
Time frame: Up to 12 months after thoracoscopy.
Sampling Quality of Pleural Biopsy Specimens
Time frame: Up to 4 weeks after thoracoscopy.
Procedure Duration
Time frame: The day of thoracoscopy.
Operator-assessed Device Performance
Time frame: Immediately after the thoracoscopic procedure
Post-thoracoscopy Pain Score
Time frame: At 2, 6, 12, 24, and 48 hours after thoracoscopy
Procedure-related Complications
Time frame: At discharge from the index hospitalization, up to 30 days after thoracoscopy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 42419899Xu L, Liu X, Wu H, Xie Z, Wang K, Deng M, Zheng Z, Hou G. Diagnostic yield and safety of Dual-functIon Semi-rigid thoraCoscOpy Versus rigid thoracoscopy for the diagnosis of plEuRal disease (DISCOVER-2): protocol for a randomised controlled trial. BMJ Open. 2026 Jul 8;16(7):e118022. doi: 10.1136/bmjopen-2026-118022.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the main publication will be made available upon reasonable request. The shared data will include baseline characteristics, allocated intervention, primary and secondary outcome data, and procedure-related complication data.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-function semi-rigid thoracoscopy and Rigid thoracoscopy in people with Pleural Effusion Disorder, run by China-Japan Friendship Hospital.
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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, MD.,PhD. (+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?
Diagnostic yield (time frame: 7 days after the procedure.). 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 NCT07114783, 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 22 Jun 2026.