Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy

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:

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.

Study Overview

• Status: Completed
• Conditions: Thoracoscopy; Pleural Effusion Disorder
• Intervention / Treatment: Procedure: Medical thoracoscopy

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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria included adult patients (>18 years) with undiagnosed pleural effusion undergoing medical thoracoscopy.

Exclusion Criteria:

Exclusion Criteria, while Medical thoracoscopy is generally safe; patients with the following conditions were excluded in accordance with reported contraindications (Jin et al., 2020):

1. 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.

2. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pleural effusion , thoracoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: FMASU R190/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No