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

Inclusion Criteria1

Undiagnosed pleural effusion with the character of a lymphocytic exudate

Exclusion Criteria7

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

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).