Exploration of the Pleural Cavity Using a fleXible endoscoPe

Not Applicable

Withdrawn

• Conditions: Pleural Effusion
• Interventions: Device: flexible video endoscope; Device: video-rigid thoracoscope

• Registration Number: NCT02463955
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracoscopy	flexible video endoscope	1. experimental intervention (flexible video endoscope) 2. reference procedure (video-rigid thoracoscope)
Thoracoscopy	video-rigid thoracoscope	1. experimental intervention (flexible video endoscope) 2. reference procedure (video-rigid thoracoscope)

Primary Outcome Measures

Name	Time	Method
Completeness of the pleural cavity exploration using the flexible endoscope	at 0 hours	Two independent experts will visualize the video-recordings of the intervention and evaluate the completeness of the exploration using a standardized score.

Secondary Outcome Measures

Name	Time	Method
Outcome of a complication	1 month	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.
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	at 0 hours	Two independent experts will visualize the video-recordings of the intervention and evaluate tee completeness of the exploration using a standardized score.
Diagnostic yield of biopsies performed with the flexible endoscope	Day 1