UnknownNot Applicable

Diagnostic Value of Bronchoscopic and Thoracoscopic Frozen Section Biopsies in Patients With Pleuropulmonary Tumors

96 participantsStarted 2022-06-15

Plain-language summary

Lung cancer is the second most commonly diagnosed cancer worldwide, after breast cancer, and its incidence continues to grow. Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision. Despite specimens are obtained under direct vision, there is a significant failure rate. This may necessitate repeating bronchoscopy. To guide the bronchoscopist on the quality and quantity of specimens during bronchoscopic biopsies for the diagnosis of lung cancer is rapid on-site evaluation (ROSE) of cytological specimens. Intra-procedural Frozen Section Evaluation (FROSE) of bronchoscopic biopsy specimens is an alternative to ROSE and helps preventing repeated bronchoscopies. Medical thoracoscopy increases the diagnostic yield of MPE as it offers the clinician a "window" for direct visualization and collection of samples from the parietal pleura.The acquracy of frozen section biopsies in pleural tumours is largely undefined. Confirmation of the pleural malignancy can lead to immediate pleurodesis following the pleural inspection and biopsy. To our knowledge limited studies discussed the value of frozen section in both bronchoscopic and thoracoscopic biopsies.

Who can participate

Age range

18 Years – 75 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.

Inclusion Criteria: * Patients presented with suspected lung neoplastic lesion indicated for bronchoscopy - * Patients presented with undiagnosed pleural effusion (suspected malignant pleural effusion) who are candidate for thoracoscopy Exclusion Criteria: * Age \<18 years old. * Contraindications for bronchoscopy: * Uncorrectable hypoxemia * Unstable angina * Uncontrolled arrhythmias * Unexplained or severe hypercarbia * Uncontrolled asthma * Uncorrectable coagulopathy * Contraindications for thoracoscopy: * Transudative pleural effusion

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

determining the spceficity and sensitivity of bronhcoscopic and thoracoscopic frozen section biopsy

Timeframe: 4 days

Trial details

NCT IDNCT05385419

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Event of Undetermined Intent (Y21-Y33) trials