NCT02463955

Exploration of the Pleural Cavity Using a fleXible endoscoPe

Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.

Detailed description

Thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. The latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. It is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. On the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. Gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. The EXPLORE study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
DEVICE	flexible video endoscope	Thoracoscopy is done using flexible video endoscope
DEVICE	video-rigid thoracoscope	Thoracoscopy is done using video-rigid thoracoscope

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2015-06-04
• Last updated: 2016-08-17