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

Primary Purpose

Pleural Effusion

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
flexible video endoscope
video-rigid thoracoscope
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion focused on measuring flexible endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Thoracoscopy

    Arm Description

    experimental intervention (flexible video endoscope) reference procedure (video-rigid thoracoscope)

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention
    Results of the microbiological analysis of samples collected on the endoscope the day of the intervention
    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.
    Diagnostic yield of biopsies performed with the flexible endoscope

    Full Information

    First Posted
    April 30, 2015
    Last Updated
    August 16, 2016
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02463955
    Brief Title
    Exploration of the Pleural Cavity Using a fleXible endoscoPe
    Acronym
    EXPLORE
    Official Title
    Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study never start
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Effusion
    Keywords
    flexible endoscopy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thoracoscopy
    Arm Type
    Experimental
    Arm Description
    experimental intervention (flexible video endoscope) reference procedure (video-rigid thoracoscope)
    Intervention Type
    Device
    Intervention Name(s)
    flexible video endoscope
    Intervention Description
    Thoracoscopy is done using flexible video endoscope
    Intervention Type
    Device
    Intervention Name(s)
    video-rigid thoracoscope
    Intervention Description
    Thoracoscopy is done using video-rigid thoracoscope
    Primary Outcome Measure Information:
    Title
    Completeness of the pleural cavity exploration using the flexible endoscope
    Description
    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 Outcome Measure Information:
    Title
    Outcome of a complication
    Description
    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
    Title
    Outcome of a complication
    Description
    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
    Title
    Outcome of a complication
    Description
    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
    Title
    Outcome of a complication
    Description
    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
    Title
    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
    Title
    Results of the microbiological analysis of samples collected on the endoscope the day of the intervention
    Time Frame
    at 0 hours
    Title
    Completeness of the pleural cavity exploration using the standard three-ports thoracoscopy with one-lung ventilation
    Description
    Two independent experts will visualize the video-recordings of the intervention and evaluate tee completeness of the exploration using a standardized score.
    Time Frame
    at 0 hours
    Title
    Diagnostic yield of biopsies performed with the flexible endoscope
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    BASTE Jean Marc, MD
    Organizational Affiliation
    Rouen University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Exploration of the Pleural Cavity Using a fleXible endoscoPe

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