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NCT Number: NCT06946498

First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sotiria General Hospital of Thoracic Diseases

Athens, Attica, 11527, Greece

Location status: Recruiting

Location contact

Michail Kon/nos Tsatsis, MD, MSc, PhD(c)

PRINCIPAL_INVESTIGATOR

Nektratios Anagnostopoulos, Ass. Professor

CONTACT

[email protected]

+306946869480

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local Anesthesia Thoracoscopy

Procedure

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.

Pleuroscopy with Rigid Thoracoscope and Forceps biopsies

Device

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).

Primary outcomes

  1. Time to Diagnosis

    Time frame: From enrollment to final diagnosis of MDT, assesed up to 12 months

    Time to diagnosis is defined as the period between the first thoracentesis ,showing a lymphocytic exudate, of a newly discovered pleural effusion in a patient without prior signs of pleural disease to the time of multi-disciplinary team final diagnosis involving a pathology report of biopsy samples.

  2. Hospitalization time

    Time frame: From enrollment to hospital discharge, assesed up to 3 months

    The time from the patient's admission in the hospital with diagnosis of unexplained lymphocytic pleural effusion until discharge with or without final diagnosis.

Secondary outcomes

  1. Patient's discomfort/pain

    Time frame: 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

    A Visual Analogue Scale (VAS) measures the intensity of pain the patient feels after the intervention (Medical Thoracoscopy vs Surgical Biopsy). A horizontal line ranging from 0 to 10, (0=No pain, 10=Extreme pain), is used. The patient is examined every day, until his discharge and is asked to mark on the line his respective level of discomfort/pain.

  2. Complications

    Time frame: 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.

    We compare the rate of post interventional complications across the two groups (Surgical biopsy vs LAT)

  3. Rate of Non Specific Pleuritis

    Time frame: Assesment up to 12 months

    We aim to asses wheter the rate of positive pleural biopsies for non specific pleuritis differed significantly between Surgical biopsy group and LAT group.

Study contacts

Contact information is provided by the study sponsor or research team.

Michail Kon/nos Tsatsis, MD, MSc, PhDc

CONTACT

[email protected]

+306979234105

Nektarios ANAGNOSTOPOULOS, Ass. professor

CONTACT

[email protected]

+306946869480

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Sotiria Thoracic Diseases Hospital of Athens

Registry information

Official study title

Local Anesthesia Thoracoscopy as a First Line Approach in the Diagnosis of Suspected Malignant Pleural Effusion: FLAT Trial.

Acronym: FLAT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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