RecruitingNot ApplicableNCT06946498

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.

Sponsor

National and Kapodistrian University of Athens

Enrollment

100 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the use of local anaesthesia thoracoscopy — a minimally invasive procedure where a small camera is inserted into the chest while the patient is awake under local anaesthesia — as the first diagnostic step for unexplained fluid around the lungs (pleural effusion). **You may be eligible if...** - You have fluid around your lungs (pleural effusion) that has not been diagnosed - The fluid appears to be a lymphocyte-rich exudate (a specific type of inflammatory fluid found on analysis) **You may NOT be eligible if...** - Your pleural fluid is due to a non-inflammatory cause (transudate) - You have an active infection in the chest (empyema) - A tumor is blocking your central airway - There are extensive scar-like adhesions that would make the procedure unsafe - You have an uncontrollable cough - You are in acute respiratory failure or have very elevated CO2 levels in your blood - You are in very poor overall health (performance status of 5) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELocal 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.

DEVICEPleuroscopy 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).

Locations(1)

Sotiria General Hospital of Thoracic Diseases

Athens, Attica, Greece

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