CompletedNot Applicable

Visual Assessment vs ROSE in Diagnosing Pleural Effusion Using Medical Thoracoscopy

Egypt33 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Absolute contraindications:
. Relative contraindications\*\*

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic Accuracy of Rapid On-Site Evaluation (ROSE) and Visual assessment

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

Trial details

NCT IDNCT07286045

SponsorAin Shams University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-15

View on ClinicalTrials.gov More Thoracoscopy trials

Plain-language summary