Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Ningbo University
About this trial
The goal of this observational study is to learn whether red dichromatic imaging (RDI) can help doctors see the bronchoscopic field more clearly after a biopsy. The study will include adults who need a bronchoscopic biopsy because doctors can see an abnormal area inside the airway.During a bronchoscopic biopsy, bleeding can happen after tissue is taken. Blood may cover the biopsy area and make it harder for doctors to see where to continue the procedure.
RDI is an imaging mode that uses special colors of light to help show blood-covered areas more clearly.The main question this study aims to answer is:Does RDI improve visibility of the bronchoscopic field after bleeding caused by bronchoscopic biopsy? Researchers will compare images taken with standard white light imaging and RDI during the same bronchoscopy procedure. Both types of images will be taken after the first biopsy and before any field-clearing treatment is done.
Participants will have bronchoscopic biopsy as part of their regular medical care, have images taken using standard white light imaging and RDI during the same procedure, have routine follow-up for possible medical problems after bronchoscopy. Taking part in this study will not add extra biopsies or change the participant's regular medical care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Visible abnormal endobronchial lesion under bronchoscopy, including endobronchial neoplasm, mucosal abnormality, airway stenosis, or other lesion requiring biopsy to determine its nature.
Provision of informed consent to participate in this clinical study and signing of the informed consent form.
Disqualifiers
Presence of contraindications to bronchoscopy, such as severe cardiopulmonary disease, coagulation dysfunction (including patients receiving anticoagulant therapy and/or anticoagulant drugs who have not discontinued these drugs for more than 5 days before the examination), poor tolerance of anesthesia, psychiatric disease, or severe neurosis.
Intra-procedural decrease in SpO₂ or inability to tolerate bronchoscopy.
Obvious airway bleeding observed during bronchoscopy that may increase the risk of worsening the patient's condition.
Images that are obviously blurred or out of focus, or that contain severe reflection, bubbles, or instrument obstruction, making subsequent image analysis impossible.
Trial population
The study population will include adults aged 18 years or older who are scheduled to undergo clinically indicated bronchoscopic biopsy at participating centers. Eligible participants will have visible airway lesions during bronchoscopy, such as endobronchial masses, mucosal abnormalities, airway stenosis, or other abnormalities that require biopsy to determine the diagnosis. The study will not include healthy volunteers. Bronchoscopy and biopsy will be performed as part of routine clinical care, and paired white light imaging and red dichromatic imaging images will be collected during the same procedure after the first biopsy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Red Dichromatic Imaging (RDI)
DeviceRed dichromatic imaging (RDI) is an optical imaging mode used during bronchoscopy. In this observational study, RDI images and standard white light imaging images will be collected during the same clinically indicated bronchoscopy procedure after the biopsy. RDI will be evaluated for its ability to improve post-biopsy bronchoscopic field visibility. The study will not assign participants to treatment groups, add extra biopsies, or change routine clinical care.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation
Paired white light imaging and red dichromatic imaging images will be assessed by independent evaluators. A bronchoscopic field will be judged suitable for direct procedural continuation if the biopsy site, lesion surface, or lesion boundary remains identifiable and biopsy or subsequent bronchoscopic procedures can continue without additional field-clearing intervention.
Time frame
PeriproceduralSecondary outcomes
1
Visual distinguishability score between the bleeding area and surrounding blood-covered background
Paired white light imaging and red dichromatic imaging images will be assessed by independent evaluators. The visual distinguishability between the biopsy-related bleeding area and the surrounding blood-covered background will be scored on a 4-point scale. A score of 1 indicates that the two areas are almost indistinguishable, and a score of 4 indicates that the two areas are clearly distinguishable and easy to identify.
Time frame
Periprocedural2
Objective color difference between the bleeding area and surrounding blood-covered background
Objective color difference will be measured using paired white light imaging and red dichromatic imaging images. Regions of interest will be selected from the biopsy-related bleeding area and the surrounding blood-covered background. Color parameters will be measured in the CIE 1976 L\*a\*b\* color space, and the overall color difference will be calculated as ΔE. Differences in the L\*, a\*, and b\* channels may also be analyzed.
Time frame
PeriproceduralOther outcomes
1
Proportion of bronchoscopic fields judged suitable for procedural continuation after one field-clearing intervention
Among cases in which both white light imaging and red dichromatic imaging are initially judged unsuitable for direct procedural continuation, one field-clearing intervention may be performed according to clinical need. This may include suction, irrigation, cold saline, topical epinephrine, or other necessary measures. After this intervention, paired white light imaging and red dichromatic imaging images will be assessed to determine whether the bronchoscopic field is suitable for continuation of biopsy or subsequent bronchoscopic procedures.
Time frame
PeriproceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Ningbo University
Lead sponsor
Shanghai Chest Hospital
Collaborator
Anhui Chest Hospital
Collaborator
Huzhou Central Hospital
Collaborator
The Second Affiliated Hospital of Jiaxing University
Collaborator
Lanxi Hospital of Traditional Chinese Medicine
Collaborator
Zhoushan Hospital of Zhejiang
Collaborator
Source ClinicalTrials.gov
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