Exploration of the Pleural Cavity Using a fleXible endoscoPe (EXPLORE)

University Hospital, Rouen

Status

Withdrawn

Conditions

Pleural Effusion

Treatments

Device: video-rigid thoracoscope

Device: flexible video endoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT02463955

2014/182/HP

2014-A01660-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.