Pleural DiseasesNCT06741839
Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease
A study testing Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy and Plerual biopsy using medical thoracoscopy in people with Pleural Diseases and Pleural Effusion, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Diseases, Pleural Effusion
- What is being tested?
- Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy and Plerual biopsy using medical thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to May 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;
- Evidence of exudative pleural effusion in which a specific diagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations
- Willingness to participate in the study and undergo an invasive procedure.;
Who cannot join
- Pleural thickening or pleural-based mass without pleural effusion on radiologic examination;
- Hemodynamic instability;
- Presence of parapneumonic effusion;
- Any contraindication to pleural biopsy or semirigid thoracoscopy;
- Participation in other studies within three months without withdrawal or termination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, +86 18801336854, isdeng1017@163.com
About this study
Official title: Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial
A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.
- Conditions
- Pleural Diseases, Pleural Effusion
- Being tested
- Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy, Plerual biopsy using medical thoracoscopy
- Medical subject headings
- Pleural Diseases, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopyProcedure or surgery
After the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE.
Plerual biopsy using medical thoracoscopyProcedure or surgery
After the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps.
| Study group | Role | What they receive |
|---|---|---|
| pCLE guided pleural biopsy via semi-rigid thoracoscopy | Experimental | pCLE will be introduced to detect suspected areas of the parietal pleura. The pCLE inspection will follow a standardized protocol with two main steps. First, any visible abnormalities under white light, such as nodules or thickening, will be examined with pCLE to evaluate intralesional heterogeneity and determine the best biopsy site. Second, the basal pleura will be systematically swept, covering at least two intercostal spaces above the costophrenic recess, including the diaphragmatic pleura and lower posterior chest wall, which are common sites for malignant involvement. After confirming the targeted area of the parietal pleura for pleural biopsy, the pCLE probe will be withdrawn, and a flexible forceps biopsy will be performed. This process will be repeated eight times, and eight samples will be obtained. All specimens will be transported in separate formalin containers with biopsy sequences for histopathological analysis. Receives: Procedure: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy |
| Conventional Pleural biopsy via semi-rigid thoracoscopy | Placebo comparator | For patients assigned to receive pleural biopsy via semi-rigid thoracoscopy alone, the parietal, visceral, and diaphragmatic pleura will be inspected, and eight biopsies will be obtained under direct vision in all suspected areas of the parietal pleura. Receives: Procedure: Plerual biopsy using medical thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The proportion of participants in whom a specific diagnosis is established following pleural biopsy via semirigid thoracoscopy, based on histopathological analysis and final reference diagnosis (including 12-month follow-up for initially benign or nonspecific results).
Measured: Up to 12 months after the procedure
Secondary outcomes (6)
Negative likelihood ratio
The negative likelihood ratio is defined as the probability of a negative biopsy result (i.e., no specific malignant or tuberculous diagnosis) in a patient who truly has the target disease (malignant pleural mesothelioma, metastatic cancer, or tuberculous pleurisy), divided by the probability of a negative biopsy result in a patient who does not have the disease.
Because pleural biopsy results have no false positives in this study (specificity = 1, false-positive rate = 0), the NLR simplifies to 1 - sensitivity.
It will be calculated using the final reference diagnosis at 12 months as the gold standard.
Measured: Up to 12 months after the procedure
Diagnostic sensitivity for specific diseases
Sensitivity of the procedure for diagnosing malignant pleural mesothelioma, metastatic cancer, and tuberculous pleurisy, as determined by the reference standard.
Measured: Up to 12 months after the procedure
Procedural time
Total duration of the thoracoscopic procedure from insertion to removal of the thoracoscope.
Measured: Day of procedure
Rate of adequate specimens for achieving molecular diagnosis
Proportion of biopsy specimens that are sufficient for predictive molecular marker analysis according to tumor type (e.g., PD-L1, EGFR, ALK, ROS-1, HER2, ER, PR, BRCA, RAS, BRAF, etc.). Specimens are categorized as: (a) successful molecular marker analysis, (b) unsuccessful molecular marker analysis (explicit test failure), (c) not sent despite relevance.
Measured: Within 2 weeks after the procedure (upon pathological reporting)
Incidence of procedure-related complications
Occurrence of any adverse events related to the procedure, including but not limited to: prolonged air leak, hemorrhage (graded as nil/slight self-limiting, mild requiring local vasoactive medication, moderate-to-severe requiring electrocautery or argon plasma coagulation), subcutaneous emphysema, postoperative fever, empyema, wound infection, cardiac arrhythmias, hypotension, and chest wall seeding from mesothelioma.
Measured: From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer)
Sampling quality (tissue depth and interpretability)
Tissue depth: Biopsy quality determined based on tissue depth (e.g., deep biopsy including fatty tissue from the thoracic wall is considered high quality).
Interpretability: Assessed as (a) easily interpretable (sufficient tissue with all diagnostic elements), (b) interpretable with some difficulty, (c) interpretable with great difficulty, (d) non-interpretable.
Measured: Within 2 weeks after the procedure (upon pathological assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start11 Mar 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 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 DiseasesStudies 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Rui Jin Hospital, Henan Provincial People's Hospital, The Second Affiliated Hospital of Harbin Medical University, Anhui Chest Hospital, Wuhan Pulmonary Hospital, Shandong Public Health Clinical Center, The Second People's Hospital of Gansu Province
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741839
- Sponsor's protocol ID
- 2022YFC2404404-3-1
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng MM, Hu Y, Liu X, Feng Y, Zheng Z, Tong R, Porcel J, Hou G. Diagnostic yield and safety of probe-based confocal laser endomicroscopy-guided pleural biopsy via semirigid thoracoscope in diagnosing patients with unknown pleural effusion: a protocol for a multicentre, randomised controlled trial (COLLABORATION-I). BMJ Open. 2026 Jun 4;16(6):e117208. doi: 10.1136/bmjopen-2026-117208.
PubMed 42242740
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06741839
- Acronym / sponsor ID
- 2022YFC2404404-3-1
- Conditions
- Pleural Diseases, Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Shanghai Rui Jin Hospital, Henan Provincial People's Hospital, The Second Affiliated Hospital of Harbin Medical University, Anhui Chest Hospital, Wuhan Pulmonary Hospital, Shandong Public Health Clinical Center, The Second People's Hospital of Gansu Province
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Dec 2024 (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.
A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pCLE guided pleural biopsy via semi-rigid thoracoscopy | Experimental | Procedure: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopypCLE will be introduced to detect suspected areas of the parietal pleura. The pCLE inspection will follow a standardized protocol with two main steps. First, any visible abnormalities under white light, such as nodules or thickening, will be examined with pCLE to evaluate intralesional heterogeneity and determine the best biopsy site. Second, the basal pleura will be systematically swept, covering at least two intercostal spaces above the costophrenic recess, including the diaphragmatic pleura and lower posterior chest wall, which are common sites for malignant involvement. After confirming the targeted area of the parietal pleura for pleural biopsy, the pCLE probe will be withdrawn, and a flexible forceps biopsy will be performed. This process will be repeated eight times, and eight samples will be obtained. All specimens will be transported in separate formalin containers with biopsy sequences for histopathological analysis. |
| Conventional Pleural biopsy via semi-rigid thoracoscopy | Placebo comparator | Procedure: Plerual biopsy using medical thoracoscopyFor patients assigned to receive pleural biopsy via semi-rigid thoracoscopy alone, the parietal, visceral, and diaphragmatic pleura will be inspected, and eight biopsies will be obtained under direct vision in all suspected areas of the parietal pleura. |
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;
- Evidence of exudative pleural effusion in which a specific diagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations
- Willingness to participate in the study and undergo an invasive procedure.;
Key exclusion criteria (5 listed)
- Pleural thickening or pleural-based mass without pleural effusion on radiologic examination;
- Hemodynamic instability;
- Presence of parapneumonic effusion;
- Any contraindication to pleural biopsy or semirigid thoracoscopy;
- Participation in other studies within three months without withdrawal or termination.
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 |
|---|---|---|
| Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopyAfter the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE. | Procedure or surgery | pCLE guided pleural biopsy via semi-rigid thoracoscopy |
| Plerual biopsy using medical thoracoscopyAfter the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps. | Procedure or surgery | Conventional Pleural biopsy via semi-rigid thoracoscopy |
Primary outcome
Diagnostic yield
Time frame: Up to 12 months after the procedure
The proportion of participants in whom a specific diagnosis is established following pleural biopsy via semirigid thoracoscopy, based on histopathological analysis and final reference diagnosis (including 12-month follow-up for initially benign or nonspecific results).
6 secondary outcomes
Negative likelihood ratio
Time frame: Up to 12 months after the procedure
Diagnostic sensitivity for specific diseases
Time frame: Up to 12 months after the procedure
Procedural time
Time frame: Day of procedure
Rate of adequate specimens for achieving molecular diagnosis
Time frame: Within 2 weeks after the procedure (upon pathological reporting)
Incidence of procedure-related complications
Time frame: From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer)
Sampling quality (tissue depth and interpretability)
Time frame: Within 2 weeks after the procedure (upon pathological assessment)
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 15 Apr 2026.
- Derived from this study: PubMed 42242740Deng MM, Hu Y, Liu X, Feng Y, Zheng Z, Tong R, Porcel J, Hou G. Diagnostic yield and safety of probe-based confocal laser endomicroscopy-guided pleural biopsy via semirigid thoracoscope in diagnosing patients with unknown pleural effusion: a protocol for a multicentre, randomised controlled trial (COLLABORATION-I). BMJ Open. 2026 Jun 4;16(6):e117208. doi: 10.1136/bmjopen-2026-117208.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy and Plerual biopsy using medical thoracoscopy in people with Pleural Diseases and Pleural Effusion, run by China-Japan Friendship Hospital at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Gang Hou (13840065481, hougangcmu@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: Up to 12 months 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 NCT06741839, 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 15 Apr 2026.