NCT02463955 - Exploration of the Pleural Cavity Using a fleXible endoscoPe | Crick

Overview

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.

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

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Pleural Effusion

Interventions

flexible video endoscopeDEVICE

Thoracoscopy is done using flexible video endoscope

video-rigid thoracoscopeDEVICE

Thoracoscopy is done using video-rigid thoracoscope

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: at 0 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 month

Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention

Time frame: Day -7 : 7 days before the intervention