Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients

Completed

• Conditions: Helicobacter Pylori Infection; Gastritis; Gastritis, Atrophic; Intestinal Metaplasia
• Interventions: Diagnostic Test: High-Definition white light endoscopy.; Diagnostic Test: High-definition magnification with digital chromoendoscopy.

• Registration Number: NCT04296513
• Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• above 18 years of age
• agreed to participate in the study
• patients with dyspepsia in accordance with Rome criteria

Exclusion Criteria

• those taking NSAIDS, PPIs or antibiotics three weeks prior invitation
• severe uncontrolled coagulopathy
• prior history of gastric surgery
• those pregnant or nursing females

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-Definition white light endoscopy.	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 magnification with digital chromoendoscopy.	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.

Primary Outcome Measures

Name	Time	Method
1. Overall accuracy of High-definition white light endoscopy to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.	3-month after index endoscopy	histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.
2. Overall accuracy of optical enhancement with optical magnification to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.	3-month after index endoscopy	histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.
3. Comparative analysis between High-definition white light endoscopy and optical enhancement with optical magnification with histological analysis.	1-month after finishing enrollment	statistical analysis of the accuracy for both diagnostic methods

Trial Locations

Locations (1)

Ecuadorian Institute of Digestive Diseases; 🇪🇨 Guayaquil, Guayas, Ecuador