Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy

NCT ID: NCT07286045

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-01

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.

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

Keywords

pleural effusion , thoracoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Medical thoracoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fathi Elbagalaty MD

Lecturer of pulmonary medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain shams university

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32642085 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

FMASU R190/2024

Identifier Type: -

Identifier Source: org_study_id