Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein

NCT ID: NCT02875600

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2021-12-31

Brief Summary

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To determine the difference in baseline MR flow measurements and post-prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI.

Detailed Description

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The diagnosis of chronic gastro-intestinal ischemia (CGI) remains a clinical challenge because this diagnosis is difficult to distinguish by the frequent incidence of chronic abdominal pain and asymptomatic stenosis of the mesenteric arteries1. The standard diagnostic work up includes medical history, anamnesis and physical examination, radiological imaging and a functional test as visible light spectroscopy (VLS)2-4 or tonometry5-7. A multidisciplinary team consisting of a gastroenterologist, a vascular surgeon and an interventional radiologist, all specialized in CGI, discusses all patients which results in an expert based consensus diagnosis. Currently, there is no specific test to diagnose CGI. In literature, Magnetic Resonance (MR) techniques are described by which the flow in the mesenteric vessels is measured pre- and post-prandial in healthy volunteers and CGI patients8-12. The flow in the mesenteric vessels increases post-prandial (hyperemia). However, this increase in post-prandial flow compared to pre-prandial appeared less in CGI patients compared to the healthy volunteers. In some CGI patients, even a decrease of the post-prandial compared to pre-prandial flow was seen. We might be able to distinguish patients with CGI from patients without CGI with MR flow measurements with food stimulation.

Conditions

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Ischemia Oxygen Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nutri drink

MRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink

Group Type EXPERIMENTAL

Nutri Drink

Intervention Type OTHER

To determine the difference in baseline MR flow measurements and post prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI

Interventions

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Nutri Drink

To determine the difference in baseline MR flow measurements and post prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients suspected of CGI referred to our hospital for further analysis
2. Age ≥ 18 years
3. Patients who gave informed consent

Exclusion Criteria

1. Age \< 18 years
2. Unable to give informed consent
3. Pregnancy
4. Contra-indications for MRI: a. Metal implants which cannot be removed. E.g. cardiac pacemakers/ICD, aneurysm clips, metal stents, artificial heart valve, cochlea/retinal implants, hearing aids, dentures with magnetic click system or with other metal accessories, tattoos with metallic dye, metal plates/pins/screws of bones, piercings b. Claustrophobia c. Inability to lie still for 1 hour to 1,5 hours
5. Other criteria the physician considers are not compatible with this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Trialbureau radiology

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Ouhlous, md

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmusmc

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Laurens Groenendijk

Role: CONTACT

31 10 7033612

Louisa Van Dijk, md

Role: CONTACT

Facility Contacts

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Laurens Groenendijk

Role: primary

31 10 7033612

Other Identifiers

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MR flow

Identifier Type: -

Identifier Source: org_study_id

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