ThoracoscopyNCT07286045
Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy
An observational study of Thoracoscopy and Pleural Effusion Disorder, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this observational diagnostic study is to find how well two evaluation methods used during medical thoracoscopy can help identify whether pleural disease is malignant or benign. The study focuses on adults undergoing thoracoscopy for undiagnosed pleural effusion or suspected pleural disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoscopy, Pleural Effusion Disorder
- What is being tested?
- Medical thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>18 years) with undiagnosed exudative pleural effusion undergoing medical thoracoscopy.
Who may be able to join
None listed.
Who cannot join
- Exclusion Criteria, while Medical thoracoscopy is generally safe; patients with the following conditions were excluded in accordance with reported contraindications (Jin et al., 2020):
- Absolute contraindications:
- Refusal to participate in the study.
- Extensive pleural adhesions (e.g., pleural fibrosis, post-infection, or prior pleurodesis).
- Inadequate pleural space for thoracoscopy.
- Relative contraindications**
Show all 10Show fewer
- Coagulopathy (platelet count <60 × 10⁹/L or INR >1.2), unless corrected prior to the procedure. The use of aspirin and clopidogrel was not considered a contraindication.
- Inability to tolerate the lateral decubitus position.
- Unstable hemodynamic status.
- Severe hypoxemia requiring high-flow oxygen therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Assessment and Rapid On-Site Evaluation for Touch Imprints From Biopsy Tissue in Diagnosing Pleural Effusion Using Medical Thoracoscopy
The goal of this observational diagnostic study is to find how well two evaluation methods used during medical thoracoscopy can help identify whether pleural disease is malignant or benign. The study focuses on adults undergoing thoracoscopy for undiagnosed pleural effusion or suspected pleural disease.
The main questions this study aims to answer are:
Read more
How accurate is the thoracoscopist's visual assessment of the pleura in predicting malignancy?
How accurate is Rapid On-Site Evaluation (ROSE) of touch-imprint cytology compared with final laboratory histopathology?
Researchers will compare thoracoscopic visual impressions with ROSE results to determine which method provides more reliable real-time diagnostic information.
Participants will:
Undergo medical thoracoscopy as part of their clinical evaluation.
Have pleural biopsy samples assessed on-site using ROSE.
Have standard histopathology testing performed for final diagnosis.
This study may help improve decision-making during thoracoscopy by identifying whether combining visual assessment with ROSE leads to faster and more accurate diagnosis of pleural disease.
Read the detailed description
Pleural effusion is a common clinical problem, and distinguishing malignant from benign causes is crucial for guiding treatment. Medical thoracoscopy allows direct visualization of the pleural surfaces and enables targeted biopsies. Although experienced clinicians often rely on the gross appearance of pleural abnormalities, visual assessment alone can be limited by overlap between malignant and benign features. Rapid On-Site Evaluation (ROSE) of touch-imprint cytology has emerged as a technique that may provide immediate microscopic information during the procedure, potentially improving diagnostic accuracy and reducing the need for repeat procedures.
This observational study prospectively evaluated the diagnostic performance of thoracoscopic visual inspection compared with ROSE during medical thoracoscopy. Thirty-three adult patients undergoing thoracoscopy for undiagnosed pleural effusion or suspected pleural disease were included. During the procedure, the thoracoscopist recorded a visual impression of whether pleural findings appeared malignant or benign. Touch-imprint slides were prepared from pleural biopsy specimens and assessed immediately by a trained cytopathologist using ROSE. All biopsy samples were subsequently analyzed by formal histopathology, which served as the reference standard.
The study measured sensitivity, specificity, accuracy, predictive values, receiver operating characteristic (ROC) curves, and agreement using Cohen's kappa. Visual assessment showed high sensitivity but limited specificity. ROSE demonstrated high overall accuracy and strong agreement with final histopathology, suggesting it may substantially improve real-time diagnostic confidence. By integrating both visual inspection and ROSE, clinicians may achieve more reliable intraoperative decision-making and potentially streamline patient management during thoracoscopy.
- Conditions
- Thoracoscopy, Pleural Effusion Disorder
- Being tested
- Medical thoracoscopy
- Keywords
- pleural effusion , thoracoscopy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopyProcedure or surgery
All participants undergo medical thoracoscopy, during which pleural surfaces are directly inspected, and targeted pleural biopsies are obtained as part of routine clinical care. During the procedure, the thoracoscopist records a gross visual impression of whether pleural findings appear benign or malignant. Touch-imprint cytology slides are prepared from biopsy samples and evaluated immediately using Rapid On-Site Evaluation (ROSE). Final histopathology of biopsy specimens serves as the diagnostic reference standard. No experimental treatments are given.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopy patients | Participants are adults undergoing medical thoracoscopy for evaluation of undiagnosed pleural effusion or suspected pleural disease. All participants receive standard-of-care thoracoscopy with pleural biopsies. During the procedure, the thoracoscopist provides a visual assessment of the pleura, and touch-imprint cytology samples are obtained for Rapid On-Site Evaluation (ROSE). Final histopathology is used as the diagnostic reference standard. Receives: Procedure: Medical thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Rapid On-Site Evaluation (ROSE) and Visual assessment
ROSE: Touch-imprint cytology slides prepared from pleural biopsy specimens are evaluated on-site by a trained cytopathologist to classify pleural disease as malignant or benign.
Thoracoscopic Visual Assessment: The thoracoscopist records a gross visual impression of the pleura as malignant or benign during the procedure.
Outcome Metrics: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), overall accuracy, and area under the receiver operating characteristic curve (AUC) for each method compared with the reference standard of histopathology.
Additional Analysis: Agreement between ROSE and histopathology will be quantified using Cohen's κ statistic.
Measured: Time Frame: During thoracoscopy (immediate assessment) with confirmation by final histopathology within 2-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2023
- Primary completion15 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThoracoscopyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathi Elbagalaty MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286045
- Sponsor's protocol ID
- FMASU R190/2024
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Rationale: This study involves diagnostic observations collected during routine clinical care. Data contain potentially identifiable patient information and are intended for internal research use only
Publications
Jin F, Wang H, Li Q, Li S, Lai G, Huang J, Huang Y, Jiang T, Bai C, Li S, Li W, Lu Y, Song Y, Sun R, Chen C, Zhang J, Zhang X, Zhou R, Zhou X, Chen Y, Du Y, Hu C, Zhou H. Expert consensus for diagnosis and treatment using medical thoracoscopy in China. J Thorac Dis. 2020 May;12(5):1799-1810. doi: 10.21037/jtd-19-2276.
PubMed 32642085Ahmed MI, El Hefny RA, Farhat ES. New challenge in double-bore medical thoracoscopy in Fayoum University Hospital. Egypt J Chest Dis Tuberc. 2024;73(1):37-43.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Assessment and Rapid On-Site Evaluation for Touch Imprints From Biopsy Tissue in Diagnosing Pleural Effusion Using Medical Thoracoscopy
- ClinicalTrials.gov ID
- NCT07286045
- Acronym / sponsor ID
- FMASU R190/2024
- Conditions
- Thoracoscopy, Pleural Effusion Disorder
- Keywords
- pleural effusion , thoracoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 Dec 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.
The goal of this observational diagnostic study is to find how well two evaluation methods used during medical thoracoscopy can help identify whether pleural disease is malignant or benign. The study focuses on adults undergoing thoracoscopy for undiagnosed pleural effusion or suspected pleural disease.
The main questions this study aims to answer are:
How accurate is the thoracoscopist's visual assessment of the pleura in predicting malignancy?
How accurate is Rapid On-Site Evaluation (ROSE) of touch-imprint cytology compared with final laboratory histopathology?
Researchers will compare thoracoscopic visual impressions with ROSE results to determine which method provides more reliable real-time diagnostic information.
Participants will:
Undergo medical thoracoscopy as part of their clinical evaluation.
Have pleural biopsy samples assessed on-site using ROSE.
Have standard histopathology testing performed for final diagnosis.
This study may help improve decision-making during thoracoscopy by identifying whether combining visual assessment with ROSE leads to faster and more accurate diagnosis of pleural disease.
Detailed description
Pleural effusion is a common clinical problem, and distinguishing malignant from benign causes is crucial for guiding treatment. Medical thoracoscopy allows direct visualization of the pleural surfaces and enables targeted biopsies. Although experienced clinicians often rely on the gross appearance of pleural abnormalities, visual assessment alone can be limited by overlap between malignant and benign features. Rapid On-Site Evaluation (ROSE) of touch-imprint cytology has emerged as a technique that may provide immediate microscopic information during the procedure, potentially improving diagnostic accuracy and reducing the need for repeat procedures.
This observational study prospectively evaluated the diagnostic performance of thoracoscopic visual inspection compared with ROSE during medical thoracoscopy. Thirty-three adult patients undergoing thoracoscopy for undiagnosed pleural effusion or suspected pleural disease were included. During the procedure, the thoracoscopist recorded a visual impression of whether pleural findings appeared malignant or benign. Touch-imprint slides were prepared from pleural biopsy specimens and assessed immediately by a trained cytopathologist using ROSE. All biopsy samples were subsequently analyzed by formal histopathology, which served as the reference standard.
The study measured sensitivity, specificity, accuracy, predictive values, receiver operating characteristic (ROC) curves, and agreement using Cohen's kappa. Visual assessment showed high sensitivity but limited specificity. ROSE demonstrated high overall accuracy and strong agreement with final histopathology, suggesting it may substantially improve real-time diagnostic confidence. By integrating both visual inspection and ROSE, clinicians may achieve more reliable intraoperative decision-making and potentially streamline patient management during thoracoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopy patients | – | Procedure: Medical thoracoscopyParticipants are adults undergoing medical thoracoscopy for evaluation of undiagnosed pleural effusion or suspected pleural disease. All participants receive standard-of-care thoracoscopy with pleural biopsies. During the procedure, the thoracoscopist provides a visual assessment of the pleura, and touch-imprint cytology samples are obtained for Rapid On-Site Evaluation (ROSE). Final histopathology is used as the diagnostic reference standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years) with undiagnosed exudative pleural effusion undergoing medical thoracoscopy.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Exclusion Criteria, while Medical thoracoscopy is generally safe; patients with the following conditions were excluded in accordance with reported contraindications (Jin et al., 2020):
- Absolute contraindications:
- Relative contraindications**
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 |
|---|---|---|
| Medical thoracoscopyAll participants undergo medical thoracoscopy, during which pleural surfaces are directly inspected, and targeted pleural biopsies are obtained as part of routine clinical care. During the procedure, the thoracoscopist records a gross visual impression of whether pleural findings appear benign or malignant. Touch-imprint cytology slides are prepared from biopsy samples and evaluated immediately using Rapid On-Site Evaluation (ROSE). Final histopathology of biopsy specimens serves as the diagnostic reference standard. No experimental treatments are given. | Procedure or surgery | Thoracoscopy patients |
Primary outcome
Diagnostic Accuracy of Rapid On-Site Evaluation (ROSE) and Visual assessment
Time frame: Time Frame: During thoracoscopy (immediate assessment) with confirmation by final histopathology within 2-7 days
ROSE: Touch-imprint cytology slides prepared from pleural biopsy specimens are evaluated on-site by a trained cytopathologist to classify pleural disease as malignant or benign. Thoracoscopic Visual Assessment: The thoracoscopist records a gross visual impression of the pleura as malignant or benign during the procedure. Outcome Metrics: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), overall accuracy, and area under the receiver operating characteristic curve (AUC) for each method compared with the reference standard of histopathology. Additional Analysis: Agreement between ROSE and histopathology will be quantified using Cohen's κ statistic.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 32642085Jin F, Wang H, Li Q, Li S, Lai G, Huang J, Huang Y, Jiang T, Bai C, Li S, Li W, Lu Y, Song Y, Sun R, Chen C, Zhang J, Zhang X, Zhou R, Zhou X, Chen Y, Du Y, Hu C, Zhou H. Expert consensus for diagnosis and treatment using medical thoracoscopy in China. J Thorac Dis. 2020 May;12(5):1799-1810. doi: 10.21037/jtd-19-2276.
- BackgroundAhmed MI, El Hefny RA, Farhat ES. New challenge in double-bore medical thoracoscopy in Fayoum University Hospital. Egypt J Chest Dis Tuberc. 2024;73(1):37-43.
- Individual participant dataSharing planned: No. Rationale: This study involves diagnostic observations collected during routine clinical care. Data contain potentially identifiable patient information and are intended for internal research use only
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoscopy and Pleural Effusion Disorder, run by Ain Shams University at 1 site in Egypt.
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 0 inclusion and 10 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: finished, as of the sponsor's last update on 19 Dec 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Rapid On-Site Evaluation (ROSE) and Visual assessment (time frame: Time Frame: During thoracoscopy (immediate assessment) with confirmation by final histopathology within 2-7 days). 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 NCT07286045, which also lists 2 linked publications.
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 19 Dec 2025.