CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Digital chromoendoscopy and magnificationdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02597517
NCT02597517N/ACompleted

Optical Enhancement System ™ Plus Optical Magnification Utility in the Identification of Normal Gastric Mucosa, Helicobacter Pylori Associated Gastritis, and Gastric Atrophy

Instituto Ecuatoriano de Enfermedades Digestivas·observational·Posted Nov 5, 2015·Updated May 3, 2016

In Brief

An observational study evaluating Digital chromoendoscopy and magnification for Gastritis and 2 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Endoscopy is a tool that has greatly influenced gastroenterological diagnosis. However, conventional endoscopy is limited to detecting lesions on the basis of gross morphological changes and therefore a certainly diagnosis depends on biopsy sampling of macroscopically obvious endoscopic features, or blind biopsy sampling of normal appearing mucosa with the risk of missed pathology and sampling errors. Gastric cancer is the second most common cause of cancer related death. One of the main roles of upper gastrointestinal endoscopy is to identify gastric cancer at an early stage. The importance of identifying H. pylori infection is because it plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. The importance of recognition a precancerous gastric lesion is because we can detect most tumors at an early stage and improve the survival. Most studies conclude that it is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is therefore currently considered to be the gold standard for detecting H. pylori infection. The reliability of detecting H. pylori infection histologically depends on the site, number, and size of gastric biopsy specimens, as well as on expertise in staining and visualizing the bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling, and neither the original nor the revised version of the Sydney system reliably identifies more than half the cases in patients with confirmed gastric atrophy.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEcuador
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 5, 2015
Enrollment StartNov 1, 2015
Primary CompletionApr 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.7 years ago

Interventions

Digital chromoendoscopy and magnificationdevice

After the gastric body mucosal evaluation with white light endoscopy, the Optical Enhancement chromoendoscopy and magnification will be used for a more detailed evaluation of the subepithelial capillary network, the collecting venules and mucosal pits