Medical Thoracoscopy With Flexible Bronchoscopy Versus Semi-Rigid Pleuroscope in Pleural Effusion (FLEXPLEUR)

Summary

Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to patients. However, the diagnosis of this condition may sometimes be difficult. In pleural effusions undiagnosed by thoracocentesis, closed pleural biopsy increases the yield by ∼10% and 40%, respectively, in malignant and tuberculous pleural effusions, whereas the diagnostic yield of thoracoscopy is ∼93% in both malignant and tuberculous pleural effusions. Hence, medical thoracoscopy (MT) (pleuroscopy) is the gold standard in the diagnosis of pleural effusion and it is indicated when less invasive tests have failed. MT is a procedure in which the pleura is directly and visually examined. An endoscope is inserted into the intercostal space by creating a pneumothorax with an incision through the chest wall. The pleural space and its lining can be inspected and therapeutic interventions performed.

There are two different techniques that can be performed for diagnostic and therapeutic thoracoscopy. One method recommends a single-entry site, the use of a usually 9-mm rigid thoracoscope (or of a semi-rigid/semi-flexible 7-mm pleuroscope) with a working channel for accessory instruments and an optical biopsy forceps, both performed under local anaesthesia. The other method requires two entry sites: one for a 7-mm trocar for the examination telescope, and the other for a 5-mm trocar for accessory instruments including the biopsy forceps, and is usually performed with conscious sedation or general anaesthesia.

In the trained hands of a pulmonologist, MT is a safe and effective procedure for diagnosing and treating multiple pleural diseases. Valsecchi et al reported a pathological diagnostic yield of 71% over a span of 30 years in around 2000 patients. The unfamiliarity of the pulmonary physician with the rigid instrument and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy even with a fibreoptic bronchoscope.

The use of a flexible fibreoptic instrument to examine the pleural space was reported by Senno et al in the 1970s in the United States. Studies showed that flexible bronchoscope, when used as a thoracoscope, maintains a clear optical field by allowing concurrent suctioning, which is analogous to the suction techniques used during flexible bronchoscopy and better views at the apex and paravertebral gutters.This method is, therefore, considered to be useful for surgeons or physicians with experience in chest drainage and flexible bronchoscopy as well as safe and well tolerated with a minimal degree of discomfort and expense.

Conditions

• Pleural Effusion

Interventions

PROCEDURE

Flexible Bronchoscopy

Subjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy

PROCEDURE

Semi-Rigid Pleuroscopy

Subjects with pleural effusion who underwent medical thorascopy using semi-rigid pleuroscopy

Sponsors & Collaborators

• National University of Malaysia

  lead OTHER

Principal Investigators

• Mohamed Faisal Abdul Hamid, MBBS (IIUM) · National University of Malaysia

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-31

Primary Completion

2024-11-01

Completion

2024-11-01

Countries

• Malaysia

Study Locations