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Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

Primary Purpose

Mediastinal Lymphadenopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EBUS-TBNA
EBUS-TBCB
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymphadenopathy

Eligibility Criteria

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

Inclusion Criteria: Patients withmediastinal lymphadenopathy of unknown cause, patients with suspected sarcoidosis or lymphoma, or patients who need to undergo EBUS-TBNA for the second time The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBCB before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc There was no contraindication of puncture and cryobiopsy No age limit, no gender limit Good compliance, able to cooperate with research and observation Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form Exclusion Criteria: The patient is allergic to lidocaine and midazolam The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer Unstable angina pectoris, congestive heart failure, severe bronchial asthma The patient did not agree to participate in this study Participation in other studies within three months without withdrawal or termination will affect the observation of this study The researcher believes that there is any person who is not suitable for the selection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    First EBUS-TBCB and then EBUS-TBNA group

    First EBUS-TBNA and then EBUS-TBCB group

    Arm Description

    The patients will undergo first endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy（EBUS-TBCB) and endobronchial ultrasound-guided transbronchial needle aspiration（EBUS-TBNA)：Routine bronchoscopy was completed, and under the guidance of EBUS, combined with CT EBUS-TBNA was used to repeatedly aspirate the tissue for 3 times (One needle is 20-50 back and forth). After the end of puncture, EBUS-TBCB was performed again, and the frozen time was about 10-15s (1.1mm cryoprobe), and the frozen time was 2-3 times to obtain at least 2 samples with a diameter of more than 5mm.

    The patients will undergo first endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and then endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB): Routine bronchoscopy was completed, combined with CT, EBUS-TBNA needle was used to determine the puncture site, and the sheath tube was used to slightly enlarge the local needle hole for EBUS-TBCB. The freezing time was about 10-15 seconds (1.1mm cryoprobe), and the freezing time was 2-3 times. To obtain at least two pieces of samples with a diameter of more than 5mm. After TBCB, EBUS-TBNA was performed in the same lymph node with 3 repeated tissue aspirations (20-50 back and back per needle).

    Outcomes

    Primary Outcome Measures

    Pathological diagnosis rate
    The diagnosis would be confirmed according to the pathological results

    Secondary Outcome Measures

    Incidence rate of adverse events
    Symptoms and signs
    Size of specimen
    measurement
    Specimen quality
    questionnaire

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    March 27, 2023
    Sponsor
    China-Japan Friendship Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05803239
    Brief Title
    Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy
    Official Title
    The Effectiveness and Safety of Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2, 2023 (Anticipated)
    Primary Completion Date
    December 24, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China-Japan Friendship Hospital

    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 goal of this clinical trial is to evaluate the diagnostic effcacy and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy. The main question it aims to answer are: the effectiveness and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy. Participants will undergo transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB) and endobronchial ultrasound-guided trans-bronchial needle aspiration (EBUS-TBNA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mediastinal Lymphadenopathy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    First EBUS-TBCB and then EBUS-TBNA group
    Arm Type
    Experimental
    Arm Description
    The patients will undergo first endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy（EBUS-TBCB) and endobronchial ultrasound-guided transbronchial needle aspiration（EBUS-TBNA)：Routine bronchoscopy was completed, and under the guidance of EBUS, combined with CT EBUS-TBNA was used to repeatedly aspirate the tissue for 3 times (One needle is 20-50 back and forth). After the end of puncture, EBUS-TBCB was performed again, and the frozen time was about 10-15s (1.1mm cryoprobe), and the frozen time was 2-3 times to obtain at least 2 samples with a diameter of more than 5mm.
    Arm Title
    First EBUS-TBNA and then EBUS-TBCB group
    Arm Type
    Experimental
    Arm Description
    The patients will undergo first endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and then endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB): Routine bronchoscopy was completed, combined with CT, EBUS-TBNA needle was used to determine the puncture site, and the sheath tube was used to slightly enlarge the local needle hole for EBUS-TBCB. The freezing time was about 10-15 seconds (1.1mm cryoprobe), and the freezing time was 2-3 times. To obtain at least two pieces of samples with a diameter of more than 5mm. After TBCB, EBUS-TBNA was performed in the same lymph node with 3 repeated tissue aspirations (20-50 back and back per needle).
    Intervention Type
    Device
    Intervention Name(s)
    EBUS-TBNA
    Intervention Description
    Participants would undergo EBUS-TBNA(NA-201SX-4022, OLYMPUS MEDICAL SYSTEMS CORP, JAPAN).
    Intervention Type
    Device
    Intervention Name(s)
    EBUS-TBCB
    Intervention Description
    Participants would undergo EBUS-TBCB(20402-401, ERBE Elektromedizin Gmbh, Germany).
    Primary Outcome Measure Information:
    Title
    Pathological diagnosis rate
    Description
    The diagnosis would be confirmed according to the pathological results
    Time Frame
    7 days after the biopsy
    Secondary Outcome Measure Information:
    Title
    Incidence rate of adverse events
    Description
    Symptoms and signs
    Time Frame
    7 days after the biopsy
    Title
    Size of specimen
    Description
    measurement
    Time Frame
    during the procedure
    Title
    Specimen quality
    Description
    questionnaire
    Time Frame
    during the procedure

    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 withmediastinal lymphadenopathy of unknown cause, patients with suspected sarcoidosis or lymphoma, or patients who need to undergo EBUS-TBNA for the second time The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBCB before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc There was no contraindication of puncture and cryobiopsy No age limit, no gender limit Good compliance, able to cooperate with research and observation Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form Exclusion Criteria: The patient is allergic to lidocaine and midazolam The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer Unstable angina pectoris, congestive heart failure, severe bronchial asthma The patient did not agree to participate in this study Participation in other studies within three months without withdrawal or termination will affect the observation of this study The researcher believes that there is any person who is not suitable for the selection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mingming Deng, MD
    Phone
    86 18801336854
    Email
    isdeng1017@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

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