Gastrointestinal BleedingNCT03243240
Computed Tomography in Gastrointestinal Bleeding
An observational study of Gastrointestinal Bleeding, run by Assiut University.
Trial summary
Gastrointestinal bleeding represents a serious clinical problem and a common cause of hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4% for lower Gastrointestinal bleeding requires a multidisciplinary approach involving gastroenterologists, endoscopists, surgeons and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- mutlidetector computed tomography
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Dec 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study. This study will be performed in Radio diagnostic department in Assiut University Hospital. We will perform multi detector computed tomography angiography with 16 or 64 multi slice computed tomography scanner. our protocol will include non enhanced scanning then perform triphasic angiography that include arterial , portal and venous phases to detect gastrointestinal bleeding.
Who may be able to join
- patients with unexplained non variceal gastrointestinal bleeding
Who cannot join
- patients with impaired renal functions or terminal liver failure. pregnancy. patients known to be sensitive to contrast media. cases diagnosed endoscopically as variceal bleeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Triphasic Computed Tomography Imaging in the Detection of Acute Non-variceal Gastrointestinal Bleeding
Gastrointestinal bleeding represents a serious clinical problem and a common cause of hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4% for lower Gastrointestinal bleeding requires a multidisciplinary approach involving gastroenterologists, endoscopists, surgeons and radiologists.
Gastrointestinal bleeding is self-limited in 80% of cases requiring only supportive measures. However, the persistence of bleeding represents a diagnostic challenge to locate the site of bleeding especially in severe bleeding and to determine, if possible its cause. This will allow to select the most appropriate therapeutic approach in order to reduce the morbidity and mortality, the length of hospitalisation and the transfusion requirements.
Read more
Current diagnostic algorithms vary widely from institution to institution and from clinician to clinician. Imaging modalities remain the mainstay of the diagnostic approach. They include endoscopy, video capsule, radionuclide imaging, catheter angiography and multidetector computed tomography imaging.
In recent years, Multidetector computed tomography has emerged as a promising technology to evaluate Gastrointestinal bleeding. The modality's ease of use and rapid results favour its use in any emergent situation. In addition, today's high-speed, narrow collimation multi-detector technology allows a large coverage area with minimal motion artifacts, with the ability to capture both arterial and venous phase with ease. Multidetector computed tomography is being increasingly used as this is a widely available, non-invasive and fast diagnostic technique that allows for visualisation of the entire intestinal tract and its lesions, the identification of vascularity and possible vascular abnormalities.
Read the detailed description
A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study.
To maximise detection capabilities, it is crucial that Computed tomography angiography should begin as soon as possible while the patient is actively bleeding. Patients with active Gastrointestinal bleeding are assigned to intensive care units, and patients in shock are promptly resuscitated. Intensive care unit physicians provide appropriate monitoring for hemodynamically unstable patients undergoing Multidetector computed tomography angiography. Multidetector computed tomography angiography should be performed without prior oral administration of water or contrast material. Active contrast material extravasation within the bowel lumen is obscured by oral contrast material, leading to false-negative results.
Data acquisition: Investigators will perform Multidetector computed tomography angiography with 16- Multislice computed tomography scanner, medical system bright speed. The protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute Gastrointestinal bleeding.
Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and Porto-venous phases, pitch 1.375, 300 Miliambiar, 120kilovolt and rotation time 0.7 seconds.
Images acquired are reconstructed for coronal, sagittal, Volume Rendering and Maximum Intensity Projection images. A similar protocol may be used with a 64-Multislice computed tomography scanner.
A dose of 1-2 ml/kg body weight of concentration 370mg/ml non-ionized contrast media will be administered at a rate of 4ml/sec, with an upper limit of 150ml. Venous access is an antecubital vein with a 14 or at least 18G cannula. The scan delay time for the arterial phase images is obtained by using bolus tracking with a circular region of interest positioned in the abdominal aorta and a predefined 90-housenfield unit bolus-trigger threshold to the start of automatic scanning. The coverage from just above the diaphragm to the Ischial tuberosities including the rectum in all cases.
Study interpretation post processing will be performed with a 4.6 version workstation. All studies are reviewed in the axial plane and with multiplanar reformation images. Real-time maximum-intensity projection images facilitate rapid study interpretation for optimal case management.
The radiologist will try to get the following information:
- presence or absence of bleeding.
- localise the site of bleeding.
- detect the cause of bleeding: tumour, Arteriovenous malformations….. The confirmation of the triphasic Multislice computed tomography results will be done by angiographic intervention and embolization of bleeding vessel
- Conditions
- Gastrointestinal Bleeding
- Being tested
- mutlidetector computed tomography
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutlidetector computed tomographyDiagnostic test
Multidetector computed tomography angiography with 16- MSCT scanner, medical system bright speed. Our protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute gastrointestinal bleeding.
Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and porto-venous phases
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of triphasic computed tomography imaging in detection of acute non variceal gastrointestinal tract bleeding
Number of 30 patients with acute gastrointestinal bleeding will undergo multislice computed tomography angiography with 16 multislice computed tomography scanner with dose 1-2ml/kg body weight contrast media and the study will be revised to detect the contrast extravasation which means active bleeding, and will detect the cause of bleeding such as tumor, aneurysm, arteriovenous malformation....and confirmation of these results will be done by angiographic intervention and embolization of the bleeding vessel
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Dec 2018 (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 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada abdelsabour, Assiut University
- Investigators
- Ghada Abdelsabour, resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243240
- Sponsor's protocol ID
- CT git bleeding
- Status last verified
- Aug 2017
- First submitted
- 10 Jul 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geffroy Y, Rodallec MH, Boulay-Coletta I, Julles MC, Ridereau-Zins C, Zins M. Multidetector CT angiography in acute gastrointestinal bleeding: why, when, and how. Radiographics. 2011 May-Jun;31(3):E35-46. doi: 10.1148/rg.313105206.
PubMed 21721196
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Triphasic Computed Tomography Imaging in the Detection of Acute Non-variceal Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT03243240
- Acronym / sponsor ID
- CT git bleeding
- Conditions
- Gastrointestinal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 8 Aug 2017 (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.
Gastrointestinal bleeding represents a serious clinical problem and a common cause of hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4% for lower Gastrointestinal bleeding requires a multidisciplinary approach involving gastroenterologists, endoscopists, surgeons and radiologists.
Gastrointestinal bleeding is self-limited in 80% of cases requiring only supportive measures. However, the persistence of bleeding represents a diagnostic challenge to locate the site of bleeding especially in severe bleeding and to determine, if possible its cause. This will allow to select the most appropriate therapeutic approach in order to reduce the morbidity and mortality, the length of hospitalisation and the transfusion requirements.
Current diagnostic algorithms vary widely from institution to institution and from clinician to clinician. Imaging modalities remain the mainstay of the diagnostic approach. They include endoscopy, video capsule, radionuclide imaging, catheter angiography and multidetector computed tomography imaging.
In recent years, Multidetector computed tomography has emerged as a promising technology to evaluate Gastrointestinal bleeding. The modality's ease of use and rapid results favour its use in any emergent situation. In addition, today's high-speed, narrow collimation multi-detector technology allows a large coverage area with minimal motion artifacts, with the ability to capture both arterial and venous phase with ease. Multidetector computed tomography is being increasingly used as this is a widely available, non-invasive and fast diagnostic technique that allows for visualisation of the entire intestinal tract and its lesions, the identification of vascularity and possible vascular abnormalities.
Detailed description
A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study.
To maximise detection capabilities, it is crucial that Computed tomography angiography should begin as soon as possible while the patient is actively bleeding. Patients with active Gastrointestinal bleeding are assigned to intensive care units, and patients in shock are promptly resuscitated. Intensive care unit physicians provide appropriate monitoring for hemodynamically unstable patients undergoing Multidetector computed tomography angiography. Multidetector computed tomography angiography should be performed without prior oral administration of water or contrast material. Active contrast material extravasation within the bowel lumen is obscured by oral contrast material, leading to false-negative results.
Data acquisition: Investigators will perform Multidetector computed tomography angiography with 16- Multislice computed tomography scanner, medical system bright speed. The protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute Gastrointestinal bleeding.
Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and Porto-venous phases, pitch 1.375, 300 Miliambiar, 120kilovolt and rotation time 0.7 seconds.
Images acquired are reconstructed for coronal, sagittal, Volume Rendering and Maximum Intensity Projection images. A similar protocol may be used with a 64-Multislice computed tomography scanner.
A dose of 1-2 ml/kg body weight of concentration 370mg/ml non-ionized contrast media will be administered at a rate of 4ml/sec, with an upper limit of 150ml. Venous access is an antecubital vein with a 14 or at least 18G cannula. The scan delay time for the arterial phase images is obtained by using bolus tracking with a circular region of interest positioned in the abdominal aorta and a predefined 90-housenfield unit bolus-trigger threshold to the start of automatic scanning. The coverage from just above the diaphragm to the Ischial tuberosities including the rectum in all cases.
Study interpretation post processing will be performed with a 4.6 version workstation. All studies are reviewed in the axial plane and with multiplanar reformation images. Real-time maximum-intensity projection images facilitate rapid study interpretation for optimal case management.
The radiologist will try to get the following information:
- presence or absence of bleeding.
- localise the site of bleeding.
- detect the cause of bleeding: tumour, Arteriovenous malformations….. The confirmation of the triphasic Multislice computed tomography results will be done by angiographic intervention and embolization of bleeding vessel
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study. This study will be performed in Radio diagnostic department in Assiut University Hospital. We will perform multi detector computed tomography angiography with 16 or 64 multi slice computed tomography scanner. our protocol will include non enhanced scanning then perform triphasic angiography that include arterial , portal and venous phases to detect gastrointestinal bleeding.
Key inclusion criteria (1 listed)
- patients with unexplained non variceal gastrointestinal bleeding
Key exclusion criteria (1 listed)
- patients with impaired renal functions or terminal liver failure. pregnancy. patients known to be sensitive to contrast media. cases diagnosed endoscopically as variceal bleeding.
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 |
|---|---|---|
| mutlidetector computed tomographyMultidetector computed tomography angiography with 16- MSCT scanner, medical system bright speed. Our protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute gastrointestinal bleeding. Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and porto-venous phases | Diagnostic test | – |
Primary outcome
Role of triphasic computed tomography imaging in detection of acute non variceal gastrointestinal tract bleeding
Time frame: one year
Number of 30 patients with acute gastrointestinal bleeding will undergo multislice computed tomography angiography with 16 multislice computed tomography scanner with dose 1-2ml/kg body weight contrast media and the study will be revised to detect the contrast extravasation which means active bleeding, and will detect the cause of bleeding such as tumor, aneurysm, arteriovenous malformation....and confirmation of these results will be done by angiographic intervention and embolization of the bleeding vessel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Background: PubMed 21721196Geffroy Y, Rodallec MH, Boulay-Coletta I, Julles MC, Ridereau-Zins C, Zins M. Multidetector CT angiography in acute gastrointestinal bleeding: why, when, and how. Radiographics. 2011 May-Jun;31(3):E35-46. doi: 10.1148/rg.313105206.
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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.
Ghada Abdelsabour, resident principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of 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 8 Aug 2017. 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?
Contact Hany Mohammed, Professor (01119159500, Hany.rad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of triphasic computed tomography imaging in detection of acute non variceal gastrointestinal tract bleeding (time frame: one year). 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 NCT03243240, 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 8 Aug 2017.