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.
Undiagnosed pleural effusion with the character of a lymphocytic exudate
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.
Parallel
Local Anesthesia Thoracoscopy
Procedure/SurgeryThe 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
DeviceA 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).
Time to Diagnosis
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
The time from the patient's admission in the hospital with diagnosis of unexplained lymphocytic pleural effusion until discharge with or without final diagnosis.
Patient's discomfort/pain
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
We compare the rate of post interventional complications across the two groups (Surgical biopsy vs LAT)
Rate of Non Specific Pleuritis
We aim to asses wheter the rate of positive pleural biopsies for non specific pleuritis differed significantly between Surgical biopsy group and LAT group.
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National and Kapodistrian University of Athens
Lead sponsor
Sotiria Thoracic Diseases Hospital of Athens
Collaborator
