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Endoscopic visible light spectroscopy: optimizing the accuracy of diagnosing chronic gastrointestinal ischemia with luminal feeding stimulation (VLS-Study)

Endoscopic visible light spectroscopy: optimizing the accuracy of diagnosing chronic gastrointestinal ischemia with luminal feeding stimulation (VLS-Study) - VLS-Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40460
Enrollment
90
Registered
2013-09-09
Start date
2014-08-05
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bowel ischemia mesenteric ischemia

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - > 18 yrs of age - capable of giving informed consent - patients suspected of chronic gastrointestinal ischemia referred to the Erasmus MC for analysis of complains;Healthy volunteers: - patent gastrointestinal arteries - unremarkable medical history - non-smoking

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
- To determine the difference in baseline mucosal oxygen saturation measurements and after luminal feeding between patients diagnosed with CGI and healthy subjects. - To determine the difference in baseline mucosal oxygen saturation measurements prior to and after treatment inpatients diagnosed with CGI with persistent relief of symptoms after treatment. - To determine the microcirculatory perfusion before and 60 minutes after luminal feeding in patients with and without CGI, using the following measurement parameters: Total vessel density (TVD [mm/mm2] or [cpll/mm2]) Perfused vessel density (PVD [mm/mm2] or [cpll/mm2]) Vessel diameters (VD [µm]) RBC velocity (RBCv [µm /sec]) Proportion of perfused vessels (PPV [%]) Microvascular flow index (MFI [AU]) Flow heterogeneity (MFIhet [AU])

Secondary

MeasureTime frame
Secondary endpoints: - To determine normal mucosal oxygen saturation measurements of the antrum, duodenal bulb and descending duodenum in healthy subjects using visible light spectroscopy. - To determine the effect of luminal feeding stimulation on mucosal oxygen saturation measurements of the antrum, duodenal bulb and descending duodenum in healthy subjects using visible light spectroscopy. - Presence of abdominal pain before and after luminal feeding stimulation, using the Numeric Pain Intensity Scale to assess the pain severity. - Time course response of luminal feeding stimulation on abdominal pain before and after 15 and 60 minutes of administering the compound liquid meal using the Numeric Pain Intensity Scale to assess the severity of pain. If pain is present, patients will be asked whether the pain is recognizable with the pain they experience after eating from before. - Presence of abdominal pain before and after luminal feeding stimulation using the Numeric Pain Intensity Scale-score to assess the pain severity in patients treated for CGI. - Time course response of luminal feeding stimulation on sublingual microcirculation before and 60 minutes of administering the compound liquid meal using the Cytocam hand-held microscope.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)