Clinical trial NCT02463955: Exploration of the Pleural Cavity Using a fleXible endoscoPe
Official title: Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pleural Effusion
Keywords: flexible endoscopy
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pleural effusion affirmed by chest radiography,
* Indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis
* Inpatient or outpatient,
* Women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained,
* For postmenopausal women, menopause confirmation of diagnosis,

Exclusion Criteria:

* Pleural effusion compression,
* Pleural effusion infected or suspected of infection,
* Febrile patient (\> 38 ° C)
* Parapneumonic effusion
* Immunosuppression (eg, neutropenia \<1G / L, immunosuppressive therapy, ...)
* Portage known multidrug-resistant germ or S. aureus resistant to methicillin,
* Clinical suspicion of tuberculosis,
* Patients who have already been treated by pleurodesis,
* Contraindication to general anesthesia,
* Contraindication of prophylactic antibiotics,
* Contraindication to pleurodesis agent
* Increased bleeding risk,
* No one deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Completeness of the pleural cavity exploration using the flexible endoscope
timeFrame: at 0 hours
Secondary outcomes:
measure: Outcome of a complication
timeFrame: at 0 hours
measure: Outcome of a complication
timeFrame: at 4 hours
measure: Outcome of a complication
timeFrame: Day 7
measure: Outcome of a complication
timeFrame: 1 month
measure: Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention
timeFrame: Day -7 : 7 days before the intervention
measure: Results of the microbiological analysis of samples collected on the endoscope the day of the intervention
timeFrame: at 0 hours
measure: Completeness of the pleural cavity exploration using the standard three-ports thoracoscopy with one-lung ventilation
timeFrame: at 0 hours
measure: Diagnostic yield of biopsies performed with the flexible endoscope
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: BASTE Jean Marc, MD
role: PRINCIPAL_INVESTIGATOR
References: