Skip to main content
OpenTrials
Completed

NCT Number: NCT02724280

Linked Color Imaging to Differentiate H. Pylori Associated Gastritis and Gastric Atrophy

H. pylori infection plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is 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. The blind biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling errors. Most studies conclude that 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastritis Atrophic Gastritis Digestive System Diseases Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Helicobacter Pylori Associated Gastritis Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, China

About this study

NBI is the most widely used system among several available image enhanced endoscopy systems. However, this technique has limitations such as dark imaging of distant lesions because of narrow-band illumination. Blue Laser Imaging (BLI) was developed to compensate for these inherent limitations of NBI. BLI uses narrow-band laser light combined with white light. This combination results in a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and the microvasculature. However, BLI still is not able to obtain sufficient brightness for distant lesions. The newly developed Linked Color Imaging (LCI) system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. This system can obtain bright endoscopic images even at a distant view because LCI has more intense white light than the short-wavelength narrow-band laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa, which means that BLI enables a clearer visualization of microvascular structures than does LCI. In contrast, LCI enhances differences in hue, in the red region of the spectrum, through digital processing. This makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. Therefore, LCI may facilitate the detection of H. pylori infection and gastric atrophy. Further studies are needed to confirm the utility of LCI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Above 18 years old patients
  • Who agree to participate in the study
  • Patients with the indications for gastroduodenoscopy

Exclusion criteria

  • Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
  • Severe uncontrolled coagulopathy
  • Prior history of gastric surgery.
  • Pregnancy and lactation

Treatment and study plan

WLE and then LCI

Device

The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.

Other names: White light endoscopy (WLE) / linked color imaging (LCI)

LCI and then WLE

Device

The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.

Other names: Linked color imaging (LCI) / White light endoscopy (WLE)

Primary outcomes

  1. Diagnosis rate of normal gastric mucosa, H. pylori associated gastritis and gastric atrophy

    Time frame: 6 months

    Number of patients with normal gastric mucosa, H. pylori associated gastritis and gastric atrophy will be calculated.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Other

Collaborators

  • People's Hospital of Guangxi Zhuang Autonomous Region
  • Second Affiliated Hospital of Soochow University
  • Shanghai 10th People's Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University

Registry information

Official study title

Linked Color Imaging (LCI) System in the Identification of Normal Gastric Mucosa, Helicobacter Pylori Associated Gastritis and Gastric Atrophy

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Nov 1, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.