First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis. (FLAT)

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Pleural Effusion, Malignant; Pleural Effusion; Mesothelioma, Malignant; Suspected Malignant Lung Neoplasm

Treatments: Procedure: Local Anesthesia Thoracoscopy; Device: Pleuroscopy with Rigid Thoracoscope and Forceps biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT06946498

FLAT1STIPNKUA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

LAT Group

Experimental group

Description:

The study group includes patients in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT) under conscious sedation. In these patients, imaging with chest CT and/or thoracic ultrasound has been performed and lymphocytic exudate is confirmed in fluid aspiration.

Treatment:

Device: Pleuroscopy with Rigid Thoracoscope and Forceps biopsies

Procedure: Local Anesthesia Thoracoscopy

Control Group

No Intervention group

Description:

The Control Group includes patients admitted with undiagnosed pleural lymphocytic exudate, who undergo Standard of Care (SOC) diagnostic strategies according to BTS guideline including among others, 3 samples for cytological examination (40-60 ml each), chest tube drainage, microbiological and immunological studies. If the diagnosis is not established and there is still indication for pleural biopsy patients are referred either for surgical biopsy or LAT.