An observational study in Gastritis, Atrophic, Helicobacter Pylori Infection and Intestinal Metaplasia, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Completed at 1 site in Ecuador. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Observational
Gastric cancer is the third most common cause of cancer-related death worldwide (1). Upper endoscopy is necessary to detect neoplastic macroscopic features at an early stage, but subtle abnormalities in the gastric mucosa are often missed or misdiagnosed (1). Helicobacter pylori (Hp) is involved in the pathogenesis of gastric diseases, such as, peptic ulcers, gastric lymphoma, and gastric cancer. Therefore, the necessity to recognize malignant gastric lesions at an early stage is imperative.
Previous I-SCAN™ technology uses white light as illumination light and digital post-processing of the reflection afterwards creates images yielding the virtual chromoendoscopic image. Emission of white light alone causes a potential limitation for the current I-SCAN™ technology to obtain high-quality images of microvascular patterns on the mucosal surface compared to narrow band imaging (NBI) with optical magnification.
Pentax Medical (HOYA, Tokyo, Japan) developed the Optical Enhancement™ (OE) System, which combines bandwidth-limited light with an endoscopy video system. The OE System combines digital signal processing with optical filters that limit the spectral characteristics of the illuminating light, connecting the peaks of the hemoglobin absorption spectrum (415 nm, 540 nm, and 570 nm) to create a continuous wavelength spectrum. This system has two modes that use different filters to optimize the visualization of specific features. Mode 1 is designed to improve visualization of microvessels with enough light. Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color (white color tone) with more light than Mode 1 filter.
In addition, high definition optical magnification endoscopes have been developed and can combine high-definition imaging with optical magnification to produce detailed images with magnification of up to 136×. This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa, enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 150 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 35 studies on the registry; 10 are open to participants now.
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A sample size was estimated with a 95% confidence interval and a 10% margin of error, based on the results of C. Robles et al. All consecutive participants will have dyspepsia according to the Rome IV criteria, and needs to be ≥18 years old. Participants need to have an epigastric pain syndrome (defined as localized pain or burning pain in the upper abdomen at least once a week, which was intermittent, nongeneralized, not relieved by defecation, and did not meet the criteria for pathology of the gallbladder or sphincter of Oddi); and/or a postprandial distress syndrome (defined as the presence of a nagging feeling of postprandial fullness after normal-volume meals, and/or early satiety that prevented the completion of a regular meal several times a week). The criteria need to be present within the 3 months prior to enrolment, and to have started ≥6 months prior to diagnosis of dyspepsia.
Exclusion Criteria:
evaluation of the gastric mucosa with high-definition white-light endoscopy (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by one endoscopist, randomly assigned via esophagogastroduodenoscopy.
Diagnostic Test: High-Definition white light endoscopy.
The subject will be evaluated by upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves the use of a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode 1 and mode 2 without optical magnification, to obtain an overview of the gastric body and identify any gross changes in the mucosa, then optical magnification will be implemented.
Diagnostic Test: High-definition magnification with digital chromoendoscopy.
evaluation of the gastric mucosa with high-definition white light endoscopy (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by
Subject will be evaluated by upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves the use of a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode 1 and mode 2 without optical magnification, to obtain an overview of the gastric body and identify any gross changes in the mucosa, then optical magnification will be implemented.
1. Overall accuracy of High-definition white light endoscopy to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.
histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.
Time frame: 3-month after index endoscopy
2. Overall accuracy of optical enhancement with optical magnification to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.
histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.
Time frame: 3-month after index endoscopy
3. Comparative analysis between High-definition white light endoscopy and optical enhancement with optical magnification with histological analysis.
statistical analysis of the accuracy for both diagnostic methods
Time frame: 1-month after finishing enrollment
Plan to share: No
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Instituto Ecuatoriano de Enfermedades Digestivas