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

October 30, 2018 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Linked Color Imaging (LCI) System in the Identification of Normal Gastric Mucosa, Helicobacter 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Affiliated Hospital to Academy of Military Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI.
Device: WLE and then LCI
The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.
Other Names:
  • White light endoscopy (WLE) / linked color imaging (LCI)
Placebo Comparator: Group B
Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE.
Device: LCI and then WLE
The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.
Other Names:
  • Linked color imaging (LCI) / White light endoscopy (WLE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-LCI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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