Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy

NCT07286045 | Completed DMC

• 1 other identifier: FMASU R190/2024
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thoracoscopy; Pleural Effusion Disorder

Keywords

pleural effusion , thoracoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Time Frame: During thoracoscopy (immediate assessment) with confirmation by final histopathology within 2-7 days

Study Arms (1)

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.

Procedure: Medical thoracoscopy

Interventions

Medical thoracoscopy PROCEDURE

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.

Thoracoscopy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>18 years) with undiagnosed exudative pleural effusion undergoing medical thoracoscopy.

You may not qualify if:

• 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\*\*
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 32642085 BACKGROUND

• Ahmed 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Pleural biopsy tissue blocks, histopathology slides, and touch-imprint cytology preparations collected during medical thoracoscopy. No genetic or genomic testing is planned.

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pulmonary medicine

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2023
• Primary Completion: May 15, 2024
• Study Completion: December 1, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)