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

NCT02724280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2018-11-01

No results posted yet for this study

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.

Conditions

  • Gastritis
  • Helicobacter Pylori Associated Gastritis
  • Atrophic Gastritis

Interventions

DEVICE

WLE and then LCI

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

DEVICE

LCI and then WLE

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

Sponsors & Collaborators

  • People's Hospital of Guangxi Zhuang Autonomous Region

    collaborator OTHER

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • Yan Liu, M.D., Ph.D. · Affiliated Hospital to Academy of Military Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2016-12-31
Completion
2017-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02724280 on ClinicalTrials.gov