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Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy

NCT07286045 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2025-12-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-05-15
Completion
2024-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286045 on ClinicalTrials.gov