Exploration of the Pleural Cavity Using a fleXible endoscoPe

Pleural Effusion Clinical Trial

— EXPLORE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02463955
• Other study ID #: 2014/182/HP
• Secondary ID: 2014-A01660-47
• Status: Withdrawn
• Phase: N/A
• First received: April 30, 2015
• Last updated: August 16, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• flexible video endoscope
Thoracoscopy is done using flexible video endoscope
• video-rigid thoracoscope
Thoracoscopy is done using video-rigid thoracoscope

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention		Day -7 : 7 days before the intervention	Yes
Secondary	Results of the microbiological analysis of samples collected on the endoscope the day of the intervention		at 0 hours	Yes
Secondary	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	No
Secondary	Diagnostic yield of biopsies performed with the flexible endoscope		Day 1	No