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NCT07726784Recruiting

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

A Pilot Randomized Controlled Trial Comparing Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope Among Hospitalized Patients With Pleural Effusion (FLEXPLEUR2)

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
36 (estimated)
First submitted
16 Jul 2026
Start date
20 Aug 2026
Primary completion date
1 Jan 2028
Lead sponsor
National University of Malaysia
NCT number
NCT07726784

What you commit to

  • Study type: Interventional
  • Planned participants: 36
  • From 20 Aug 2026 to the primary completion date, 1 Jan 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous ipsilateral pleurodesis or thoracic surgery significantly altering pleural anatomy

Other illness

  • Uncontrolled cardiac arrhythmia or recent acute coronary syndrome
  • Severe pulmonary hypertension with high procedural risk

Lab values

  • Uncorrectable coagulopathy (e.g., platelet count \<50,000/µL, INR \>1.5 despite correction)

Age

  • Age \< 18 years

Other

  • Patients with contraindications to perform medical thoracoscopy, e.g.:
  • Severe hypoxemia not correctable with supplemental oxygen
  • Hemodynamic instability
  • Extensive pleural adhesions or obliterated pleural space on imaging
  • Inability to tolerate lateral decubitus position
  • Refusal to provide informed consent
  • Pregnancy

Who the study is looking for

  • 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Canselor Tuanku Muhriz, National University of Malaysia,
Coordinator of this site? Confirm its status
CherasMalaysiaRecruiting
Faculty of Medicine, Hospital CAnselor Tuanku Muhriz UKM
Coordinator of this site? Confirm its status
Kuala LumpurMalaysiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.