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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02724280
Enrollment
253
Registered
2016-03-31
Start date
2016-09-01
Completion date
2017-02-01
Last updated
2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Gastritis, Gastritis, Helicobacter Pylori Associated Gastritis

Brief summary

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.

Detailed description

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.

Interventions

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

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

Sponsors

People's Hospital of Guangxi Zhuang Autonomous Region
CollaboratorOTHER
Shanghai 10th People's Hospital
CollaboratorOTHER
Second Affiliated Hospital of Soochow University
CollaboratorOTHER
Sixth Affiliated Hospital, Sun Yat-sen University
CollaboratorOTHER
Affiliated Hospital to Academy of Military Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis rate of normal gastric mucosa, H. pylori associated gastritis and gastric atrophy6 monthsNumber of patients with normal gastric mucosa, H. pylori associated gastritis and gastric atrophy will be calculated.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026