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

Starting soon · Not applicable

Conditions studied: Malignant Pleural Effusions (Mpe), Medical Thoracoscopy, Pleural Effusion

In brief

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.

Key facts

Study ID

NCT07726784

Run by

National University of Malaysia

People needed

36

Starts

2026-09-01

Expected to finish

2028-06-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Age < 18 years
• Patients with contraindications to perform medical thoracoscopy, e.g.:
• Uncorrectable coagulopathy (e.g., platelet count <50,000/µL, INR >1.5 despite correction)
• Severe hypoxemia not correctable with supplemental oxygen
• Hemodynamic instability
• Extensive pleural adhesions or obliterated pleural space on imaging
• Uncontrolled cardiac arrhythmia or recent acute coronary syndrome
• Severe pulmonary hypertension with high procedural risk
• Inability to tolerate lateral decubitus position
• Refusal to provide informed consent
• Pregnancy
• Previous ipsilateral pleurodesis or thoracic surgery significantly altering pleural anatomy

Where it is running

• Hospital Canselor Tuanku Muhriz, National University of Malaysia, — Cheras, Kuala Lumput, Malaysia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.