NCT03243240

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

July 10, 2017

Last Update Submit

August 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • patients with unexplained non variceal gastrointestinal bleeding

You may not qualify if:

  • patients with impaired renal functions or terminal liver failure. pregnancy. patients known to be sensitive to contrast media. cases diagnosed endoscopically as variceal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21721196BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ghada Abdelsabour, resident

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany Mohammed, Professor

CONTACT

Omran Khodary, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 10, 2017

First Posted

August 8, 2017

Study Start

September 1, 2017

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

August 8, 2017

Record last verified: 2017-08