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
About this trial
This is an interventional diagnostic trial for Lower Gastrointestinal Bleeding
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
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
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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