Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion

Description

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 provides limited yield, whereas the diagnostic yield of thoracoscopy is substantially higher for 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 rigid thoracoscope (or of a semi-rigid/semi-flexible 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 trocar for the examination telescope, and the second 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. The unfamiliarity of the pulmonary physician with rigid instruments and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy with flexible endoscopes. Flexible instruments allow concurrent suctioning to maintain a clear optical field, providing good views at the apex and paravertebral gutters. This method is considered useful for physicians with experience in chest drainage and flexible bronchoscopy, as well as safe and well tolerated with a minimal degree of discomfort and expense.

Interventions

• Single-Use Flexible Bronchoscope (Device)
  The investigational device evaluated in this study is the UE Medical Single-Use Flexible Bronchoscope, a sterile disposable flexible endoscope equipped with a 2.8-mm working channel. The device is designed to visualize the pleural cavity and permit pleural tissue sampling with standard biopsy forceps during medical thoracoscopy. Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.
• Semi-Rigid Pleuroscope (Device)
  The comparator device is the Olympus LTF-260 Semi-Rigid Pleuroscope, which represents the current standard-of-care instrument used for medical thoracoscopy at Hospital Canselor Tuanku Muhriz (HCTM) UKM. The semi-rigid pleuroscope features a flexible distal tip and a 2.8-mm working channel, enabling visualization of the pleural cavity and tissue acquisition during pleural biopsy. Both devices are intended to achieve the same clinical objectives, namely pleural cavity inspection and pleural tissue sampling. The primary difference is that the investigational device is a single-use, disposable, flexible bronchoscope, whereas the comparator is a reusable, semi-rigid pleuroscope routinely used in clinical practice.

Eligibility criteria

Conditions

Locations

• Faculty of Medicine, Hospital CAnselor Tuanku Muhriz UKM — Kuala Lumpur, Kuala Lumpur, Malaysia
• Hospital Canselor Tuanku Muhriz, National University of Malaysia, — Cheras, Kuala Lumput, Malaysia