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.
Age > 18 years
Patient presents with an undifferentiated pleural effusion with or without initial diagnostic thoracocentesis, thereby necessitating definitive pleural tissue sampling.
Demonstrated presence of a visually significant pleural effusion occupying at least one-third of the affected hemithorax on standard chest radiography, or a visually confirmed loculated effusion accessible via thoracic ultrasound mapping.
The patient has demonstrated full willingness to participate and has signed the formal written informed consent form approved by the institutional review board.
Age < 18 years
Uncorrectable coagulopathy (e.g., platelet count <50,000/µL, INR >1.5 despite correction)
Severe hypoxemia not correctable with supplemental oxygen
Hemodynamic instability
Parallel
Single-Use Flexible Bronchoscope
DeviceThe 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
DeviceThe 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.
Feasibility rate (in percentage) of medical thoracoscopy using a single-use flexible bronchoscope compared with the conventional semi-rigid pleuroscope
Reported as a single percentage: the proportion of trial cases meeting 100% of defined feasibility criteria. Individual measures (recruitment consent, intervention delivery, protocol adherence, technical pleural entry including visualization and biopsy, procedural completion without crossover, and 48-hour follow-up) will be evaluated per participant. The final reported value is calculated as: Overall Feasibility Rate (%)= Number of participants meeting all 7 feasibility criteria ÷ Total number of enrolled participants X 100%
Difference in procedure duration (in minutes) between the single-use flexible bronchoscope and the conventional semi-rigid pleuroscope to evaluate time-efficiency.
Total duration of the medical thoracoscopy procedure in minutes, measured from the time the videoscope enters the pleural cavity through the trocar until complete removal of the videoscope from the trocar at the end of the procedure. This duration will be recorded in minutes for analysis.
Procedural success rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
The percentage of participants in each treatment group achieving procedural success, defined as successful entry into the pleural space and adequate tissue sample collection without requiring device crossover.
Difference in immediate procedural and disposable hardware costs between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
Total cost per participant for single-use devices, disposables, and procedural equipment, tracked via standard trial micro-costing inventory sheets at the time of procedure.
Diagnostic Yield Rate (in percentage) between Single-Use Flexible Bronchoscope and Conventional Semi-Rigid Pleuroscope
The percentage of participants in each group for whom pleural biopsy samples yielded a definitive histopathological or microbiological diagnosis.
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