Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy|
- The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin [ Time Frame: within 14 days of enrollment ] [ Designated as safety issue: No ]
- Longitudinal extent of villous changes in the small bowel will be evaluated. [ Time Frame: within 14 days of enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||July 2007|
Device: Capsule Endoscopy
Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.
These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.
Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.
Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.
The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.
Capsule Endoscopy could become an important tool for the non-invasive assessment of small bowel mucosa in GSE.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555737
|United States, Massachusetts|
|University of Massachusetts Memorial Medical Center|
|Worcester, Massachusetts, United States, 01655|
|University of Tampere Medical School|
|Ospedale Maggiore - Policlinico|
|Milano, Italy, 20122|
|Universita Cattolica del Sacro Cuore|
|San Giovanni A.S. Hospital|
|Principal Investigator:||Roberto de Franchis, MD, Prof.||Ospedale Maggiore - Policlinico, Milano, Italy|