NCT06946498

First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Diagnostic approach of patients with with unexplained lymphocytic exudate is the main subject of the study. Minimally invasive techniques (single entry thoracoscopy with local anesthesia -LAT) have been developed for the definitive biopsy of the parietal pleura, with which, in addition to the diagnosis, a therapeutic pleurodesis can be performed at the same time. Usually, diagnostic LAT is performed only after 3 negative pleural fluid cytological tests have been performed, thus delaying the diagnostic access and treatment of the patient. The aim of this study is to evaluate the conventional diagnostic approach used in daily clinical practice (3 consecutive punctures of pleural effusion with cytological examination and in case of insufficient diagnosis pleural biopsy, either LAT or VATS depending on the clinical assessment of the patient) with the simplest immediate performance of LAT as soon as a pleural effusion suspected of malignancy is detected. Thus two subject groups will be compared. The first (LAT Group) will undergo Local Anesthesia Thoracoscopy as the first line option for the diagnosis of the suspected MPE. The control group will undergo the standard of care recommended guidelines for the diagnosis of MPE.

Conditions

• Suspected Malignant Lung Neoplasm
• Pleural Effusion
• Pleural Effusion, Malignant
• Mesothelioma, Malignant

Interventions

Type	Name	Description
PROCEDURE	Local Anesthesia Thoracoscopy	The patient is placed in a lateral decubitus, with the affected hemithorax upwards. Ensuring a venous line and full monitoring of vital functions. Mild sedation is given and a dose of Ceftriaxone is given 30 minutes before. Local anesthesia is injected in layers, starting from the skin and working up to the intercostal muscles, intercostal nerve, and periosteum of the rib. Development of pneumothorax is done using a 16-gauge Boutin needle. 15 spontaneous breaths are sufficient to create a pneumothorax, and entry of rigid thoracoscope into the hemithorax through a 11-13 mm Trocar. Multiple biopsies from the parietal pleura are taken and pleurodesis is made according to operator judgment. A chest drain 20-22 G is placed and sutured. A chest X-ray is performed 2-8 hours later after the patient is transferred to the ward. Chest drain is removed after 24h if fluid production is \<250ml and lung re-expansion.
DEVICE	Pleuroscopy with Rigid Thoracoscope and Forceps biopsies	A video thoracoscope with an external light source, outer diameter 10 mm (Karl Storz), is inserted into the pleural cavity through a uniportal incision (1 - 1.5 cm) and complete inspection of the pleural cavity is performed. Parietal pleural biopsies are taken with a rigid 40 mm forceps (Karl Storz).

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: Greece