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

Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein With Food Stimulation in Patients Suspected of Chronic Gastro-intestinal Ischemia

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.

Study Overview

• Status: Unknown
• Conditions: Ischemia; Oxygen Deficiency
• Intervention / Treatment: Other: Nutri Drink

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015CE
      • Recruiting
      • ErasmusMC
      • Principal Investigator: Mohamed Ouhlous, MD
      • Sub-Investigator: Louisa van DIjk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutri drink; MRI flow measurements of mesenterial vessels and portal vein before and after stimulation with nutritional drink	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of difference in baseline MR flow measurements and post prandial MR flow	The difference in baseline MR flow measurements and post prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI (mL/min/kg)	2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wich vessel or combination of vessels differentiate best	Which vessel or which combination of vessels best differentiates between patients diagnosed with CGI and patients not diagnosed with CGI by MR flow measurement by computing sensitivity, specificity, predictive positive value and negative predictive value.	2.5 years
The severity of abdominal pain	The severity of abdominal pain in course of time after stimulation with nutritional drink, using the Numeric Pain Intensity scale at baseline and 20, 30 and 40 minutes after nutritional drink	20/30/40 minutes
Determination of difference in MR flow measurements before and after treatment for CGI	The difference in MR flow measurements of the mesenteric vessels prior to and after treatment in patients diagnosed with CGI with persistent relief of symptoms after treatment (in (mL/min/kg)	2.5 years

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Mohamed Ouhlous, md, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: chronic gastro-intestinal ischemia; oxygen deficiency of the gastro-intestinal tract
• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Respiratory; Ischemia; Hypoxia
• Other Study ID Numbers: MR flow

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO