NCT03449602

Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study. One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups: Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions

Detailed description

A significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. In this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope. This is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh. Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups: Group A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm. Group B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm. Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
DEVICE	Mini-thoracoscopy	Thoracoscopic pleural biopsy with the mini-thoracoscope
DEVICE	Conventional rigid thoraoscopy	Thoracoscopic pleural biopsy with the conventional rigid thoraoscope

Timeline

• Start date: 2018-03-01
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2018-02-28
• Last updated: 2023-03-29

Locations

1 site across 1 country: India