Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy

Ain Shams University33 enrolled

Overview

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.

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.

Interventions

Medical thoracoscopyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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