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MSCT Angiography in Bleeding

Primary Purpose

Lower Gastrointestinal Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multislice CT Angiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Gastrointestinal Bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients presenting to assiut university hospital with active lower gastrointestinal bleeding.

Exclusion Criteria:

  • Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients with GIT bleeding

    Arm Description

    Patients with active lower Gastrointestinal bleeding

    Outcomes

    Primary Outcome Measures

    MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding.
    Multislice ct angiography

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    March 7, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03464513
    Brief Title
    MSCT Angiography in Bleeding
    Official Title
    Role of MSCT Angiography in Evaluation of Lower Gastrointestinal Bleeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    April 1, 2019 (Anticipated)
    Study Completion Date
    April 1, 2020 (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
    Lower gastrointestinal bleeding occurs distal to the ligament of treitz and may involve the small bowel, colon and rectum . Active lower gastrointestinal bleeding is a common, potentially life threatening medical presentation that can be challenging to localize and treat . There are many diseases that may cause lower gastrointestinal bleeding, including angiodysplasia, diverticulosis, benign or malignant bowel neoplasm, inflammatory bowel disease, ischemic bowel disease, and infectious bowel disease. Often, gastrointestinal bleeding will stop spontaneously, but in approximately 25% of patients, bleeding is massive or recurrent, requiring imaging localization and directed therapy.
    Detailed Description
    Accurate and prompt diagnosis of the bleeding source is crucial because mortality can be as high as 40%if there is hemodynamic instability in patients . Because of the length of GI tract, the multitude of pathologic processes that can result in GI bleeding, imaging plays a primary role in the diagnosis . Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding . MSCTA is being increasingly used because it is a widely available, non-invasive and fast diagnostic technique that allows for the visualization of the entire intestinal tract and its lesions, the identification of the vascularity and possible vascular abnormalities. In addition, this technique does not require preparation in patients with acute bleeding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lower Gastrointestinal Bleeding

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with GIT bleeding
    Arm Type
    Other
    Arm Description
    Patients with active lower Gastrointestinal bleeding
    Intervention Type
    Device
    Intervention Name(s)
    Multislice CT Angiography
    Intervention Description
    Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding.
    Primary Outcome Measure Information:
    Title
    MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding.
    Description
    Multislice ct angiography
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients presenting to assiut university hospital with active lower gastrointestinal bleeding. Exclusion Criteria: Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16484350
    Citation
    Yoon W, Jeong YY, Shin SS, Lim HS, Song SG, Jang NG, Kim JK, Kang HK. Acute massive gastrointestinal bleeding: detection and localization with arterial phase multi-detector row helical CT. Radiology. 2006 Apr;239(1):160-7. doi: 10.1148/radiol.2383050175. Epub 2006 Feb 16.
    Results Reference
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    MSCT Angiography in Bleeding

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