Minimally Invasive Endoscopy in Diffuse Lung Disease
Primary Purpose
Lung Disease, Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Confocal microscopy and endocytoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Disease focused on measuring Confocal microscopy, Endocytoscopy, Diffuse lung disease, Minimally invasive, Lung cancer and dysplasia
Eligibility Criteria
Inclusion Criteria:
- Age 16 or over
- Scheduled for bronchoscopy as part of clinical care
- No bleeding diathesis or therapeutic anticoagulation
Exclusion Criteria:
- Unable to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bronchoscopy
Arm Description
Outcomes
Primary Outcome Measures
To determine characteristic features of different lung disease on confocal microscopy and endocytoscopy.
Secondary Outcome Measures
Rate of complications and side-effects over and above standard bronchoscopy.
Full Information
NCT ID
NCT00934778
First Posted
June 12, 2009
Last Updated
November 24, 2016
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT00934778
Brief Title
Minimally Invasive Endoscopy in Diffuse Lung Disease
Official Title
Evaluation of Two Minimally Invasive Endoscopic Techniques for the Diagnosis of the Diffuse Lung Diseases.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We want to compare 2 new systems for obtaining very detailed images of the smallest airways, in the hope that they can be used to provide useful information about lung diseases without the need for invasive tests.
Two new systems have been developed for use down the bronchoscope, which provide video imaging of the smallest airways, each system looking at a different aspect of the structure of the airway walls. In principal, this method could provide useful information which may reduce the need for a surgical lung biopsy. We will therefore be assessing the value of the additional information obtained with these two new systems.
The purpose of this research project is to gather information using both systems to gain a greater understanding of the tissue characteristics of various diseases without the need for a biopsy.
Detailed Description
Diffuse lung disease (DLD) remains a challenging area for diagnosis and treatment. Features suggestive of the various histological subtypes of DLD can be obtained from the clinical history and examination, and can also seen on cross-sectional imaging (high resolution computed tomography (HRCT) scanning), however final diagnosis very often relies on the results of more invasive testing. The gold-standard diagnostic tool is the surgical lung biopsy, but this requires a general anaesthetic and either thoracoscopy or thoracotomy. The morbidity and even mortality attached to this approach in these patients, many of whom have significant respiratory compromise, has resulted in less invasive techniques being employed in many instances. At present, this involves the use of bronchoalveolar lavage (BAL) and transbronchial biopsies via the fibreoptic bronchoscope. BAL can be distressing for patients if there is spill-over of lavage fluid into the larger airways, and transbronchial biopsies lead to significant bleeding or pneumothorax in around 5% of patients. Even with biopsies and BAL, some patients still progress to surgical lung biopsy.
There have recently been developed 2 systems for use via the working channel of the endoscope which provide imaging of the distal airways and alveoli in vivo and in real time. These are described below. In principal, these could provide diagnostic information in the setting of DLD without the need for biopsies or BAL, reducing morbidity and cost associated with sample processing, and shortening the time to diagnosis. The ideal situation would be that sufficient morphological and histological information could be obtained using these systems, thus obviating altogether the need for surgical biopsy in this patient group, providing further benefits for the patient and potentially huge cost savings for institutions.
Cellvizio® Lung (Mauna Technology) Confocal microscopy is the standard tool for ultrahigh resolution imaging in biomedical research. Mauna Technology has developed a 1.4mm diameter Alveoflex Confocal Miniprobe™ which can be deployed down the working channel of a standard bronchoscope. Elastin is the main in vivo fluorophore, and images are acquired by gentle contact, providing microstructural detail of the alveolus on multiple tissue layers. Because the system takes advantage of the natural fluorescence of the lung tissues, no patient preparation is required.
Endocytoscope system (ECS) The endocytoscope is a newly developed system that can be passed through the working channel of a standard bronchoscope, and provides high magnification views (x450) of cell surfaces. About 5mls of 0.5% methylene blue solution is used to stain the area of interest, and images are obtained by contact with the cell surface. Use of the ECS has already been shown to allow discrimination between normal and abnormal tissue in situ in the setting of bronchial dysplasia and malignancy.
Aim of research The purpose of this research project is to build up a database of information gathered using both systems so that features correlating with the different diffuse lung diseases (e.g. sarcoidosis, interstitial pneumonias, drug induced lung diseases, emphysema) can be recorded. Patients with normal lung parenchyma and focal disease such as lung cancer will also be evaluated in order to develop a better understanding of pulmonary morphology using these techniques. By using two potentially complimentary systems that look at different structural aspects of the target tissues, a greater understanding of in vivo tissue characteristics can be gained. It is hoped that diagnostic criteria can then be drawn up for individual diseases that can then be assessed prospectively in trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Lung Cancer
Keywords
Confocal microscopy, Endocytoscopy, Diffuse lung disease, Minimally invasive, Lung cancer and dysplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bronchoscopy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Confocal microscopy and endocytoscopy
Intervention Description
2 probe based imaging systems for use via the working channel of the bronchoscope. 0.5ml of methylene blue injected into airways for endocytoscopy. Each procedure takes about 2-3 minutes.
Primary Outcome Measure Information:
Title
To determine characteristic features of different lung disease on confocal microscopy and endocytoscopy.
Time Frame
Interim analysis every 20 cases
Secondary Outcome Measure Information:
Title
Rate of complications and side-effects over and above standard bronchoscopy.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 16 or over
Scheduled for bronchoscopy as part of clinical care
No bleeding diathesis or therapeutic anticoagulation
Exclusion Criteria:
Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pallav Shah, MBBS, MD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Minimally Invasive Endoscopy in Diffuse Lung Disease
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