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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Thoracoscopy is done using flexible video endoscope
Thoracoscopy is done using video-rigid thoracoscope
Completeness of the pleural cavity exploration using the flexible endoscope
Two independent experts will visualize the video-recordings of the intervention and evaluate the completeness of the exploration using a standardized score.
Time frame: at 0 hours
Outcome of a complication
Complications are defined by any of the following: any grade \>2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Time frame: at 0 hours
Outcome of a complication
Complications are defined by any of the following: any grade \>2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Time frame: at 4 hours
Outcome of a complication
Complications are defined by any of the following: any grade \>2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Time frame: Day 7
Outcome of a complication
Complications are defined by any of the following: any grade \>2 event of the Clavien-Dindo classification, a documented or suspected infection, a non programmed admission to the hospital, a prolongation of hospitalization, or death.
Time frame: 1 month
Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention
Time frame: Day -7 : 7 days before the intervention
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Results of the microbiological analysis of samples collected on the endoscope the day of the intervention
Time frame: at 0 hours
Completeness of the pleural cavity exploration using the standard three-ports thoracoscopy with one-lung ventilation
Two independent experts will visualize the video-recordings of the intervention and evaluate tee completeness of the exploration using a standardized score.
Time frame: at 0 hours
Diagnostic yield of biopsies performed with the flexible endoscope
Time frame: Day 1