Clinical trial NCT06946498: First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.
Official title: Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suspected Malignant Lung Neoplasm
Pleural Effusion
Pleural Effusion, Malignant
Mesothelioma, Malignant
Keywords: Malignant Pleural Effusion
Local Anesthesia Thoracoscopy
Medical Thoracoscopy
Lung cancer
Mesothelioma
Lymphocytic Exudate
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Sotiria Thoracic Diseases Hospital of Athens
First posted: 2025-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Diagnosis
timeFrame: From enrollment to final diagnosis of MDT, assesed up to 12 months
measure: Hospitalization time
timeFrame: From enrollment to hospital discharge, assesed up to 3 months
Secondary outcomes:
measure: Patient's discomfort/pain
timeFrame: Day 1: immediately post-procedure. Day 2: 24hours post-procedure. Day 3 up to Day of tube removal: Every 24 hours. Time frame ends on removal of chest tube or patient dishcarge, assesment up to 2 weeks
measure: Complications
timeFrame: Day 1: immediately post-procedure. Day 2: 24hours post-procedure. Day 3 up to Day of tube removal: Every 24 hours. Time frame ends on removal of chest tube or patient dishcarge, assesment up to 3 months.
measure: Rate of Non Specific Pleuritis
timeFrame: Assesment up to 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sotiria General Hospital of Thoracic Diseases
state: Attica
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Grigorios Stratakos, Professor
role: STUDY_DIRECTOR
References:
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