After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's
esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is
needed for CLE but is not part of the investigation.
Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed
baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal
mucosa.
Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according
to randomisation) will be injected intravenously. Endoscopist and assistant staff will be
blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5
min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of
fluorescein into the gut lumen and widening of intervillous space.
Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin
catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to
visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast
cell tryptase to identify mast cell activation and numbers.
The procedure will take around 15 minutes in addition to the routine investigation performed
prior to the study. A study outline is presented in figure 1.
Samples taken are the same amount as done in the previous food associated study.
Phase:
N/A
Details
Lead Sponsor:
University Hospital Schleswig-Holstein University of Schleswig-Holstein