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

RecruitingNAAges 18 Years - anyAllNational University of Malaysia
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In plain words

What the trial is, and whether it could suit you

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 sp

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๐Ÿ“‹ Eligibility rules (as published)
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/ยตL, 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
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What it tests

  • Single-Use Flexible Bronchoscope
  • Semi-Rigid Pleuroscope
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Where

2 sites
Faculty of Medicine, Hospital CAnselor Tuanku Muhriz UKM
Kuala Lumpur, Malaysia
Hospital Canselor Tuanku Muhriz, National University of Malaysia,
Cheras, Malaysia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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