Feasibility of a disposable flexible bronchoscope for thoracoscopy compared with a semi-rigid pleuroscope in pleural effusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two tools for medical thoracoscopy (pleuroscopy) in adults with pleural effusion. It measures feasibility by successful pleural entry, visualization, tissue biopsy, and completing the procedure without switching devices. Secondary outcomes include procedure duration, overall success rates, immediate costs, and early complication rates (within 48 hours). The trial aims to determine if the disposable flexible bronchoscope is a viable alternative to the conventional semi-rigid pleuroscope. Lead coordination is by the National University of Malaysia across two hospitals in Kuala Lumpur and Cheras.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

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

Study contacts

• Principal investigator: Mohamed Faisal Abdul Hamid, MBBS(IIUM) — Principal Investigator
• Study coordinator: Mohamed Faisal Abdul Hamid, MBBS(IIUM)
• Email: faisal.hamid@hctm.ukm.edu.my
• Phone: +603-91456082

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.