The aim of this study is to evaluate a dynamic MRI protocol with physiological stimulation of gastrointestinal motility as a non-invasive method for diagnosing CIPO.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the response of small bowel motility to a food
stimulus in CIPO patients, expressed as the ratio between the postprandial
motility score and the interdigestive motility score, measured with dynamic
MRI.
Secondary outcome
- To evaluate if the oral intake of a small-volume test meal is feasible in
CIPO patients or if a nasogastric/duodenal tube is necessary.
- To assess if there are differences in interdigestive and postprandial
motility values of CIPO patients and healthy volunteers.
- To assess if there are differences in motility of CIPO patients with a
neurogenic and patients with a myogenic cause of the disease.
Background summary
Chronic intestinal pseudo-obstruction (CIPO) is a severe digestive disease
caused by neurogenic and/or muscular failure of intestinal motility. The
reference diagnostic test to unambiguously demonstrate CIPO is antroduodenal
manometry, which is an invasive, burdensome and cumbersome test that is not
widely available. Recently, dynamic MRI has emerged as a non-invasive method
for evaluating small bowel motility. In this study, a novel dynamic MRI
protocol with physiological stimulation will be evaluated to diagnose CIPO.
Study objective
The aim of this study is to evaluate a dynamic MRI protocol with physiological
stimulation of gastrointestinal motility as a non-invasive method for
diagnosing CIPO.
Study design
Eight CIPO patients will undergo a MRI protocol comprising of several baseline
fasting state dynamic MRI scans and subsequently several postprandial dynamic
MRI scans after taking in a liquid test meal (200 mL of Nutridrink, 300 kcal).
Small bowel motility will be quantified using a validated post-processing
technique, resulting in a motility score. Motility of CIPO patients will be
compared with healthy volunteers that underwent a similar protocol in a
previous study. Recruitment will take place via the treating physician at the
gastroenterology clinic.
Intervention
All subjects will receive a test meal consisting of a standardized 300-kCal
liquid meal (Nutridrink) with a volume of 200 mL. If oral intake seems not
possible as assessed by the treating gastroenterologist due to a substantial
risk of vomiting, a nasogastric or duodenal tube will be placed for intake of
the test meal.
Study burden and risks
The ingestion of the test meal in this patient group can induce nausea and
vomiting with a small risk of aspiration. To prevent this, patients will be
screened by a clinician with experience treating this group and the risk of
vomiting will be estimate, if this is substantial a nasogastric tube will be
placed. This can be uncomfortable but has minimal risks, a method (Cortrak®)
without need for imaging with ionizing radiation will be used. Risks for the MR
examination are minimal, MRI is a diagnostic procedure without direct
therapeutic effects. The time burden will be a one-time visit early in the
morning of maximally 1,5 hours.
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Willing to give informed consent
Willing to undergo MRI
18 years or older
Willing to receive a small-volume test meal either orally or via a nasogastric/duodenal tube
Diagnosed with CIPO based on symptoms of intestinal occlusion and findings at antroduodenal manometry compatible with CIPO (abnormal propagation of phase 3 or abnormally low contraction amplitudes)
Exclusion criteria
Being unable to give informed consent
Inability to hold breath for 20 seconds
Contraindications to undergo MRI (certain neuroclips, pacemaker, claustrophobia, pregnancy)
Contraindication for ingredients in the test meal (Nutridrink Juice style apple)
Substantial risk of vomiting after intake of the test meal (which cannot be solved by placing a nasogastric or duodenal tube), as assessed by a clinician with experience treating this patient group
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 |
|---|---|
| CCMO | NL63706.018.18 |