Pleural Effusion DisorderConfocal laserNCT07040241
Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy
A study testing Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy and Ultrasound-guided pleural biopsy in people with Pleural Effusion Disorder, run by China-Japan Friendship Hospital.
Trial summary
This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion. 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?
- Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy and Ultrasound-guided pleural biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 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
- Adult patients with exudative pleural effusion of unknown origin
- Patients with negative pleural fluid cytology results
- Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation
- Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an informed consent form
Who cannot join
- Inability or refusal to undergo UGBx
- Patients with any contraindications for pleural biopsy
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: Diagnostic Yield and Safety of Probe-based COnfocaL LAser Endomicroscopy and Ultrasound-guided Pleural BiOpsy in Diagnosing Patients With Unknown pleuRAl Effusion: a Protocol of a Multicenter, Randomized cONtrolled Trial (COLLABORATION-Ⅱ）
This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.
- Conditions
- Pleural Effusion Disorder
- Being tested
- Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy, Ultrasound-guided pleural biopsy
- Keywords
- Pleural effusion, Confocal laser endomicroscopy, 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.
Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsyProcedure or surgery
Also called CLE-assisted ultrasound-guided pleural biopsy
Using the probe-based confocal laser endomicroscopy to detect the pleural, and ensure the biopsy location. Then, use the pleural biopsy tool to complete the pleural biopsy. The whole procession will under the ultrasound guidance.
Ultrasound-guided pleural biopsyProcedure or surgery
Using ultrasound to detect the biopsy site and perform pleural biopsy.
| Study group | Role | What they receive |
|---|---|---|
| CLE-assisted ultrasound-guided pleural biopsy | Experimental | The patients in this arm will receive the CLE-assisted ultrasound-guided pleural biopsy Receives: Procedure: Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy |
| Ultrasound-guided pleural biopsy | Placebo comparator | The patients in this arm will receive the ultrasound-guided pleural biopsy Receives: Procedure: Ultrasound-guided pleural biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.
Measured: The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 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
- NCT07040241
- Sponsor's protocol ID
- 2025-COLLABERATION-Ⅱ
- Acronym
- Confocal laser
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Z, Ye S, Liu X, Xiao K, Deng M, Tong R, Porcel JM, Wang T, Hou G. Diagnostic yield and safety of needle-based COnfocaL LAser endomicroscopy and ultrasound-guided pleural BiOpsy in diagnosing patients with unknown pleuRAl effusion: a protocol for a mulTIcenter, randomized cONtrolled trial (COLLABORATION-II). Respir Res. 2026 Apr 23;27(1):245. doi: 10.1186/s12931-026-03674-7.
PubMed 42026599
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield and Safety of Probe-based COnfocaL LAser Endomicroscopy and Ultrasound-guided Pleural BiOpsy in Diagnosing Patients With Unknown pleuRAl Effusion: a Protocol of a Multicenter, Randomized cONtrolled Trial (COLLABORATION-Ⅱ）
- ClinicalTrials.gov ID
- NCT07040241
- Acronym / sponsor ID
- Confocal laser / 2025-COLLABERATION-Ⅱ
- Conditions
- Pleural Effusion Disorder
- Keywords
- Pleural effusion, Confocal laser endomicroscopy, Pleural biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jun 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.
This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLE-assisted ultrasound-guided pleural biopsy | Experimental | Procedure: Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsyThe patients in this arm will receive the CLE-assisted ultrasound-guided pleural biopsy |
| Ultrasound-guided pleural biopsy | Placebo comparator | Procedure: Ultrasound-guided pleural biopsyThe patients in this arm will receive the ultrasound-guided pleural biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with exudative pleural effusion of unknown origin
- Patients with negative pleural fluid cytology results
- Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation
- Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an informed consent form
Key exclusion criteria (2 listed)
- Inability or refusal to undergo UGBx
- Patients with any contraindications for pleural biopsy
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 |
|---|---|---|
| Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsyAlso: CLE-assisted ultrasound-guided pleural biopsyUsing the probe-based confocal laser endomicroscopy to detect the pleural, and ensure the biopsy location. Then, use the pleural biopsy tool to complete the pleural biopsy. The whole procession will under the ultrasound guidance. | Procedure or surgery | CLE-assisted ultrasound-guided pleural biopsy |
| Ultrasound-guided pleural biopsyUsing ultrasound to detect the biopsy site and perform pleural biopsy. | Procedure or surgery | Ultrasound-guided pleural biopsy |
Primary outcome
Diagnostic yield
Time frame: The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.
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 27 Jun 2025.
- Derived from this study: PubMed 42026599Zheng Z, Ye S, Liu X, Xiao K, Deng M, Tong R, Porcel JM, Wang T, Hou G. Diagnostic yield and safety of needle-based COnfocaL LAser endomicroscopy and ultrasound-guided pleural BiOpsy in diagnosing patients with unknown pleuRAl effusion: a protocol for a mulTIcenter, randomized cONtrolled trial (COLLABORATION-II). Respir Res. 2026 Apr 23;27(1):245. doi: 10.1186/s12931-026-03674-7.
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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 Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy and Ultrasound-guided pleural biopsy 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 4 inclusion and 2 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 27 Jun 2025. 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. Some participants in this study may receive a placebo. 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, Doctor (+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: The day 7 after patients received CLE-assisted ultrasound-guided pleural 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 NCT07040241, 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 27 Jun 2025.