Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.

What this Trial Is About

Researchers are evaluating diagnostic approaches for patients with unexplained lymphocytic pleural effusion suspected to be malignant. The study compares two groups: one undergoing immediate Local Anesthesia Thoracoscopy (LAT) for pleural biopsy and the other receiving the standard diagnostic care involving multiple pleural fluid cytological tests followed by biopsy if needed. The goal is to assess the effectiveness, sensitivity, hospitalization duration, and safety between these methods. Patients in the study group receive LAT under conscious sedation, where local anesthesia is applied and biopsy samples are taken through a thoracoscope. This procedure also allows for therapeutic pleurodesis if needed. The control group is managed with standard care, including at least three pleural fluid cytology samples and other diagnostic tests, with biopsy referrals made if diagnosis remains uncertain. Both groups undergo imaging and laboratory evaluations as clinically indicated. Participants are monitored for time to diagnosis and hospital stay length, with assessments extending up to 12 months for diagnosis and 3 months for hospitalization. Additional evaluations include patient discomfort and pain immediately post-procedure and daily until chest tube removal or discharge, as well as monitoring for complications and rates of non-specific pleuritis. Follow-up includes chest X-rays and clinical evaluations, ensuring comprehensive safety and outcome tracking during the study period.

First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.