RECRUITINGINTERVENTIONAL

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.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Undiagnosed pleural effusion with the character of a lymphocytic exudate Who Should NOT Join This Trial: - 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. - Acute respiratory failure and/or Hypercapnia. - Performance Status: 5 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Undiagnosed pleural effusion with the character of a lymphocytic exudate Exclusion Criteria: * 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. * Acute respiratory failure and/or Hypercapnia. * Performance Status: 5

Treatments Being Tested

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).

Locations (1)

Sotiria General Hospital of Thoracic Diseases

Athens, Attica, Greece