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. To gather information on the potential of endoscopic mitochondrial oxygen…
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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
- To gather information on the potential of endoscopic mitochondrial oxygen
measurements in diagnosing CGI in patients suspected of CGI.
Secondary outcome
- To determine which vessel or which combination of vessels best differentiates
between patients diagnosed with CGI and patients not diagnosed with CGI by MR
flow measurement
- 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.
- To determine 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.
Background summary
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
postprandial (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.
As mentioned it is standard practice to perform a functional test such as VLS
and tonometry, but both have limitations. An easy-to-use and accurate
functional test to diagnose CGI is highly desired. Protoporphyrin IX-triplet
state lifetime technique (PpIX-TSLT) is a novel method used to measure oxygen
in mitochondria13. After administration of 5-aminolevulinicacid (ALA)
mitochondrial PpIX increases. Green light is used to excite PpIX during the
measurements, inducing light emission. After collision with oxygen molecules
PpIX returns to its ground state, ceasing light emission. The duration of light
emission is measured. When few mitochondrial oxygen is present, collisions are
less likely to occur resulting in a longer duration of light emission. A
previous study has proven feasibility of endoscopic mitochondrial oxygen
measurements in volunteers. Yet no information on the potential of endoscopic
mitochondrial oxygen measurements in diagnosing CGI in patients suspected of
CGI is available.
Study objective
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. To gather information on the potential of endoscopic
mitochondrial oxygen measurements in diagnosing CGI in patients suspected of
CGI.
Study design
Prospective cohort study.
Study burden and risks
The MR flow measurements will take 1 hour to 1.5 hour during one additional
visit besides the standard work-up for CGI patients. No contrast agent or
radiation is used for the MR flow measurements. Because most patients with CGI
present with post-prandial pain, abdominal pain may occur when stimulation with
the nutritional drink starts. We will be aware of this pain and ask the patient
several times if the pain occurs and stop if necessary.
The risks of mitochondrial oxygen measurements during routine upper endoscopy
are very low, especially when no sedation is used. Oral administration of
Gliolan (for PpIX induction) has a good safety profile. The risk of mucosal
phototoxicity during upper endoscopy is considered low, since the COMET uses
short-pulsed excitation and very low total light dosage. To limit the potential
effects of phototoxicity, patients will be instructed to avoid exposure to
direct sunlight of eyes and skin for 24 hours after administration of Gliolan.
's Gravendijkwal 210
Rotterdam 3015 CE
NL
's Gravendijkwal 210
Rotterdam 3015 CE
NL
Listed location countries
Age
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
6. Contra-indications for MitoO2 measurements:
a. Acute or chronic porphyria
b. Hypersensitivity for ALA or porphyrin
c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline
phosphatase (ALP), or bilirubin of >2 times upper limit of normal
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT02875600 |
CCMO | NL54995.078.15 |