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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01660-47 | Other Identifier | ANSM |
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study never start
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracoscopy | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flexible video endoscope | Device | Thoracoscopy is done using flexible video endoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 0 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 0 hours |
| Outcome of a complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BASTE Jean Marc, MD | University Hospital, Rouen | Principal Investigator |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| video-rigid thoracoscope |
| Device |
Thoracoscopy is done using video-rigid thoracoscope |
|
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. |
| 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. | 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. | 1 month |
| Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention | Day -7 : 7 days before the intervention |
| Results of the microbiological analysis of samples collected on the endoscope the day of the intervention | 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. | at 0 hours |
| Diagnostic yield of biopsies performed with the flexible endoscope | Day 1 |