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

Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax

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.

Study Overview

• Status: Withdrawn
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: flexible video endoscope; Device: video-rigid thoracoscope

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracoscopy; experimental intervention (flexible video endoscope); reference procedure (video-rigid thoracoscope)	Device: flexible video endoscope; Thoracoscopy is done using flexible video endoscope; Device: video-rigid thoracoscope; Thoracoscopy is done using video-rigid thoracoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: BASTE Jean Marc, MD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: flexible endoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 2014/182/HP; 2014-A01660-47 (Other Identifier: ANSM)