Exploration of the Pleural Cavity Using a fleXible endoscoPe

NCT ID: NCT02463955

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-07-31

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.

Conditions

Pleural Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Thoracoscopy

1. experimental intervention (flexible video endoscope)

2. reference procedure (video-rigid thoracoscope)

Group Type: EXPERIMENTAL

flexible video endoscope

Intervention Type: DEVICE

Thoracoscopy is done using flexible video endoscope

video-rigid thoracoscope

Intervention Type: DEVICE

Thoracoscopy is done using video-rigid thoracoscope

Interventions

flexible video endoscope

Thoracoscopy is done using flexible video endoscope

Intervention Type: DEVICE

video-rigid thoracoscope

Thoracoscopy is done using video-rigid thoracoscope

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BASTE Jean Marc, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Other Identifiers

2014-A01660-47

Identifier Type: OTHER

Identifier Source: secondary_id

2014/182/HP

Identifier Type: -

Identifier Source: org_study_id