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Role of Ultrasound Elastography in Pleural Effusion

Primary Purpose

Pleural Effusion

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

About this trial

This is an interventional diagnostic trial for Pleural Effusion

Eligibility Criteria

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

Inclusion Criteria: .patients with pleural effusion above18 year Exclusion Criteria: patients who refuse to undergone further investigations to reach final diagnosis of cause of pleural effusion .patients with intercostal tube inserted in the effusion before enrollment in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    transudate effusion

    exudative effusion

    Arm Description

    Outcomes

    Primary Outcome Measures

    detect diagnostic performance of ultrasound elastography in pleural effusion
    differentiate between elastisty index in benign and malignant pleural effuison that expressed in kpa by measuring it using ultrasound elastography

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2022
    Last Updated
    December 6, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05642091
    Brief Title
    Role of Ultrasound Elastography in Pleural Effusion
    Official Title
    Role of Ultrasound Elastography in Pleural Effusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 13, 2022 (Anticipated)
    Primary Completion Date
    August 13, 2025 (Anticipated)
    Study Completion Date
    August 2026 (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
    Diagnostic performance of u.s elastography in pleural effusion
    Detailed Description
    Pleural fluid is an extremely common problem however the diagnosis of pleural effusion remain challenging due its diverse aetiologies .transthoracic ultrasound is often the initial tool to help diagnosis of pleural effusion. Ultrasound elastography is a novel ultrasound technology that can differentiate malignant disease from benign disease by quantitatively assses tissue stifness by measuring the degree of distortion under application of an external force (shear wave ) However, very limited studies are available evaluating the efficacy of this novel technique in diagnosis of malignant pleural effusion.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    transudate effusion
    Arm Type
    Active Comparator
    Arm Title
    exudative effusion
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    ultrasound Elastography
    Intervention Description
    application of shear wave force by ultrasound elastography
    Primary Outcome Measure Information:
    Title
    detect diagnostic performance of ultrasound elastography in pleural effusion
    Description
    differentiate between elastisty index in benign and malignant pleural effuison that expressed in kpa by measuring it using ultrasound elastography
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: .patients with pleural effusion above18 year Exclusion Criteria: patients who refuse to undergone further investigations to reach final diagnosis of cause of pleural effusion .patients with intercostal tube inserted in the effusion before enrollment in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mai Assem Abd-elkareem, resisdent doctor
    Phone
    +201000970497
    Email
    maiassem620@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzan Salama sayed, professor
    Phone
    +201014236163
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    doaa mohamed magdy, associate prof
    Organizational Affiliation
    assuit university hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    sahar refaat mahmoud, lecturer
    Organizational Affiliation
    assuit university hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20696692
    Citation
    Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.
    Results Reference
    background
    PubMed Identifier
    31151959
    Citation
    Jiang B, Li XL, Yin Y, Zhang Q, Zang T, Song WS, Wang XM, Kang J, Herth FJF, Hou G. Ultrasound elastography: a novel tool for the differential diagnosis of pleural effusion. Eur Respir J. 2019 Aug 22;54(2):1802018. doi: 10.1183/13993003.02018-2018. Print 2019 Aug.
    Results Reference
    background
    PubMed Identifier
    12728147
    Citation
    Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available.
    Results Reference
    background
    PubMed Identifier
    4642731
    Citation
    Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.
    Results Reference
    background
    PubMed Identifier
    30054348
    Citation
    Bibby AC, Dorn P, Psallidas I, Porcel JM, Janssen J, Froudarakis M, Subotic D, Astoul P, Licht P, Schmid R, Scherpereel A, Rahman NM, Cardillo G, Maskell NA. ERS/EACTS statement on the management of malignant pleural effusions. Eur Respir J. 2018 Jul 27;52(1):1800349. doi: 10.1183/13993003.00349-2018. Print 2018 Jul.
    Results Reference
    background
    PubMed Identifier
    20696688
    Citation
    Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.
    Results Reference
    background

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    Role of Ultrasound Elastography in Pleural Effusion

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