Tests a numbing chest scope as first step for suspected malignant pleural effusion
Tests chest scope biopsy first in adults with suspected malignant pleural effusion.
Key facts
- Who runs it
- National and Kapodistrian University of Athens
- Where
- Athens, GreeceSee the site
- Trial code
- Registry title
- First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 23 May 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Local Anesthesia Thoracoscopy
- Pleuroscopy with Rigid Thoracoscope and Forceps biopsies
- Record updated
- 27 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 90 whose pleural effusion (fluid around the lung) has no diagnosis yet and looks like a lymphocytic exudate. It tests starting the work-up with a thoracoscopy biopsy under local anaesthesia.
- Age
- 18 to 90 years
- Sex
- Women and men can join.
- Disease stage
- Undiagnosed pleural effusion with the character of a lymphocytic exudate; a malignant cause is suspected.
Main reasons for not taking part
- Empyema (pus in the pleural space)
- Transudate pleural effusion
- Central airway blocked by a tumour
- Extensive adhesions that do not allow safe entry of the thoracoscope
- Uncontrollable cough, or acute respiratory failure or high carbon dioxide in the blood (hypercapnia)
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Undiagnosed pleural effusion with the character of a lymphocytic exudate
Who cannot take part
- Acute respiratory failure and/or Hypercapnia
- Empyema
- Transudate pleural effusion
- Central airway obstruction by tumor
- Existence of extensive adhesions that do not allow the development of iatrogenic pneumothorax and the safe entry of the thoracoscope
- Uncontrollable cough
- Performance Status: 5
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in Greece
- Sotiria General Hospital of Thoracic DiseasesAthens, GreeceContact: Nektratios Anagnostopoulos, Ass. ProfessorTaking people
About the trial
What the trial wants to find out
Non randomized study with two groups. The study group includes patients with suspected malignant pleural effusion, in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT).
Read full original descriptionShow less
The Control Group includes patients who come to the same hospital and are treated with the Standard of Care (SOC) strategies were used. Efficacy of LAT, Sensitivity, Hospitalization, time to diagnosis and general safety and comfort of the groups' subjects will be assessed.
The 2 groups in the trial
- LAT GroupTreatment being tested
The study group includes patients in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT) under conscious sedation. In these patients, imaging with chest CT and/or thoracic ultrasound has been performed and lymphocytic exudate is confirmed in fluid aspiration.
Treatment: Local Anesthesia Thoracoscopy and Pleuroscopy with Rigid Thoracoscope and Forceps biopsies
- Control GroupNo study treatment, for comparison
The Control Group includes patients admitted with undiagnosed pleural lymphocytic exudate, who undergo Standard of Care (SOC) diagnostic strategies according to BTS guideline including among others, 3 samples for cytological examination (40-60 ml each), chest tube drainage, microbiological and immunological studies. If the diagnosis is not established and there is still indication for pleural biopsy patients are referred either for surgical biopsy or LAT.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.
- Plain-language title
- Tests a numbing chest scope as first step for suspected malignant pleural effusionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06946498, who can take part
- Record updated
- 27 April 2025