Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients
NCT ID: NCT04296513
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2020-03-01
2020-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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High-Definition white light endoscopy.
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.
High-Definition white light endoscopy.
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
High-definition magnification with digital chromoendoscopy.
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.
High-definition magnification with digital chromoendoscopy.
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.
Interventions
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High-Definition white light endoscopy.
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
High-definition magnification with digital chromoendoscopy.
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.
Eligibility Criteria
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Inclusion Criteria
* agreed to participate in the study
* patients with dyspepsia in accordance with Rome criteria
Exclusion Criteria
* severe uncontrolled coagulopathy
* prior history of gastric surgery
* those pregnant or nursing females
18 Years
80 Years
ALL
No
Sponsors
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Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
Responsible Party
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Locations
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Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, Ecuador
Countries
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References
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Hussain I, Ang TL. Evidence based review of the impact of image enhanced endoscopy in the diagnosis of gastric disorders. World J Gastrointest Endosc. 2016 Dec 16;8(20):741-755. doi: 10.4253/wjge.v8.i20.741.
Robles-Medranda C, Valero M, Puga-Tejada M, Oleas R, Baquerizo-Burgos J, Soria-Alcivar M, Alvarado-Escobar H, Pitanga-Lukashok H. High-definition optical magnification with digital chromoendoscopy detects gastric mucosal changes in dyspeptic-patients. World J Gastrointest Endosc. 2020 Jan 16;12(1):23-32. doi: 10.4253/wjge.v12.i1.23.
Other Identifiers
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IECED-02012020
Identifier Type: -
Identifier Source: org_study_id
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