Lower Gastrointestinal BleedingNCT03464513
MSCT Angiography in Bleeding
A study testing Multislice CT Angiography in people with Lower Gastrointestinal Bleeding, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lower Gastrointestinal Bleeding
- What is being tested?
- Multislice CT Angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients presenting to assiut university hospital with active lower gastrointestinal bleeding.
Who cannot join
- Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency
About this study
Official title: Role of MSCT Angiography in Evaluation of Lower Gastrointestinal Bleeding
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.
Read the 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.
- Conditions
- Lower Gastrointestinal Bleeding
- Being tested
- Multislice CT Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multislice CT AngiographyDevice
Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Patients with GIT bleeding | Other | Patients with active lower Gastrointestinal bleeding Receives: Device: Multislice CT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding.
Multislice ct angiography
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Gergis Naeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464513
- Sponsor's protocol ID
- Angiography
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16484350
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MSCT Angiography in Evaluation of Lower Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT03464513
- Acronym / sponsor ID
- Angiography
- Conditions
- Lower Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GIT bleeding | Other | Device: Multislice CT AngiographyPatients with active lower Gastrointestinal bleeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting to assiut university hospital with active lower gastrointestinal bleeding.
Key exclusion criteria (1 listed)
- Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multislice CT AngiographyMultislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding. | Device | Patients with GIT bleeding |
Primary outcome
MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding.
Time frame: 1 hour
Multislice ct angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Background: PubMed 16484350Yoon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multislice CT Angiography in people with Lower Gastrointestinal Bleeding, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSCTA in the evaluation of patients presenting with active lower gastrointestinal bleeding. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.