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Completed

NCT Number: NCT04296513

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

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.

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Key information

Conditions

Gastritis, Atrophic Digestive System Diseases Gastritis Gastroenteritis Gastrointestinal Diseases Helicobacter Pylori Infection Intestinal Metaplasia Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Definition white light endoscopy.

Diagnostic Test

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.

Diagnostic Test

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 outcomes

  1. 1. Overall accuracy of High-definition white light endoscopy to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

    Time frame: 3-month after index endoscopy

    histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

  2. 2. Overall accuracy of optical enhancement with optical magnification to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

    Time frame: 3-month after index endoscopy

    histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.

  3. 3. Comparative analysis between High-definition white light endoscopy and optical enhancement with optical magnification with histological analysis.

    Time frame: 1-month after finishing enrollment

    statistical analysis of the accuracy for both diagnostic methods

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Registry information

Official study title

High-Definition White Light Endoscopy vs Optical Enhancement With High Definition Optical Magnification in the Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients: A Randomized Controlled Trial.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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