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Role of Bronchoscope in Diagnosis of Lung Cancer

Primary Purpose

Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bronchoscope
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement. Exclusion Criteria: patients with no evidence of malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    bronchial wash group

    bronchial brush

    Arm Description

    the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained

    the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained

    Outcomes

    Primary Outcome Measures

    comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis
    we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    September 13, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05992740
    Brief Title
    Role of Bronchoscope in Diagnosis of Lung Cancer
    Official Title
    The Optimal Sequence of Bronchial Brushing, Forceps Biopsy and Washing for Diagnosis of Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2025 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy.
    Detailed Description
    Lung cancer is the most common cause of cancer-related mortality in both sexes in the world. To treat the disease successfully, it should be diagnosed at the earliest possible stage. Several studies have demonstrated that early detection, localization, and aggressive treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been developed using flexible fiber-optic bronchoscopy (FOB). Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable diagnostic yields ranging from37-77%. One reason for this variability is limitations in tissue sampling techniques, which can make it impossible to obtain the most representative area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and transbronchial needle aspiration, have been evaluated in various combinations to improve the diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear and requires further study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    analytical cross sectional
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    bronchial wash group
    Arm Type
    Active Comparator
    Arm Description
    the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained
    Arm Title
    bronchial brush
    Arm Type
    Active Comparator
    Arm Description
    the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained
    Intervention Type
    Device
    Intervention Name(s)
    bronchoscope
    Intervention Description
    bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy
    Primary Outcome Measure Information:
    Title
    comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis
    Description
    we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement. Exclusion Criteria: patients with no evidence of malignancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    merna maged
    Phone
    +201284143158
    Email
    mernamaged1@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    manal ahmed
    Phone
    +201009493236

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27076949
    Citation
    Hou G, Miao Y, Hu XJ, Wang W, Wang QY, Wu GP, Wang EH, Kang J. The optimal sequence for bronchial brushing and forceps biopsy in lung cancer diagnosis: a random control study. J Thorac Dis. 2016 Mar;8(3):520-6. doi: 10.21037/jtd.2016.02.12.
    Results Reference
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    PubMed Identifier
    31974454
    Citation
    Lim JH, Kim MJ, Jeon SH, Park MH, Kim WY, Lee M, Kim JH, Kim JS, Kim YS, Kim L, Lee KH, Kwak SM, Shin H, Nam HS. The optimal sequence of bronchial brushing and washing for diagnosing peripheral lung cancer using non-guided flexible bronchoscopy. Sci Rep. 2020 Jan 23;10(1):1036. doi: 10.1038/s41598-020-58010-w.
    Results Reference
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    Role of Bronchoscope in Diagnosis of Lung Cancer

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