First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.

Not Applicable

Recruiting

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

• Registration Number: NCT06946498
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Study Start: 2023-05-23
• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Diagnosis	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.
Hospitalization time	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 Outcome Measures

Name	Time	Method
Patient's discomfort/pain	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.
Complications	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)
Rate of Non Specific Pleuritis	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.

Trial Locations

Locations (1)

Sotiria General Hospital of Thoracic Diseases; 🇬🇷 Athens, Attica, Greece