Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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). 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Undiagnosed pleural effusion with the character of a lymphocytic exudate
Locations
Other Locations
Greece
Sotiria General Hospital of Thoracic Diseases
RECRUITING
Athens
Contact Information
Primary
Nektarios ANAGNOSTOPOULOS, Ass. professor
aris.anag@yahoo.gr
+306946869480
Backup
Michail Kon/nos Tsatsis, MD, MSc, PhDc
tsatsis.mihail@gmail.com
+306979234105
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: LAT Group
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.
No_intervention: Control Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Sotiria Thoracic Diseases Hospital of Athens
Leads: National and Kapodistrian University of Athens