Diagnosis Ability of Linked Color Imaging for Helicobacter Pylori Infection Compared With White Light Imaging

January 3, 2017 updated by: Bai Yang, Kashgar 1st People's Hospital
There are lack of endoscopic criteria for diagnosing Helicobacter pylori (H. pylori) infection by conventional white light imaging (WLI). Linked color imaging (LCI) is a newly developed endoscopy technique, which can diagnose mucosal lesions and H. pylori infection by enhancing color contrast of the mucosa. The aim of the study is to investigate the ability of LCI for diagnosing H. pylori infection compared with WLI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections in man. And it is the causative factor for peptic ulcer and regarded as a class I carcinogen for gastric adenocarcinoma. Therefore, accurate detection of infection is crucial for devising proper eradication regimens and preventing the more severe GI complications. Detection of H. pylori in the gastric mucosa can be performed via (1) direct detection of the bacterium; culture, histology and polymerase chain reaction or (2) indirect detection of its enzymatic products particularly urease and serum H. pylori-specific antibody examinations. The direct detection methods are complicated and time-consuming. While the indirect detection methods are less accurate. With the wide use of endoscopy, diagnosis of H. pylori infection by endoscopy should be more accurate and easily available. However, there are still lack of endoscopic criteria for diagnosing H. pylori infection by conventional white light imaging (WLI), which correlates poorly with histopathological findings of H. pylori-induced gastritis . The newly modified LCI system (FUJIFILM Co.) can obtain clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light. LCI technique can enhance the color of the endoscopic images by digital processing, which makes red regions seem redder and white regions seem whiter. Therefore, LCI may facilitate the detection of certain kinds of gastric lesions. As the common thinking, H. pylori-associated gastritis regions are redder than normal mucosa under WLI because of hyperemia following inflammation. And such redness can be enhanced by LCI. However, there is no criterion for this estimating. Red, green and blue (RGB) color model is a basic component system of the hue, of which each color is a composition of different proportions. Thus, the color obtained by endoscopic images can be quantified by RGB model. The study aimed at comparing the ability of WLI and LCI for diagnosing H. pylori infection by using RGB color model and investigating objective and quantifiable endoscopic criteria for predicting H. pylori infection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Xinjiang
      • Kashgar, Xinjiang, China, 0998
        • Recruiting
        • First People's Hospital of Kashgar Region
        • Contact:
        • Principal Investigator:
          • Bai Yang, Doctor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People who undergo esophagogastroduodenoscopy in the First People's Hospital of Kashgar Region. All patients provided written informed consents to undergo esophagogastroduodenoscopy and participate in this study.

Description

Inclusion Criteria:

  • People who undergo esophagogastroduodenoscopy for possible upper gastrointestinal disease

Exclusion Criteria:

  • Patients who have taken proton pump inhibitor, antibiotics, non-steroidal anti-inflammatory drugs, bismuth agent, H2-receptor inhibitor and medicines that can affect the test of H. pylori infection in a month
  • Patients with severe systematic disorders
  • Patients with accurate gastrointestinal bleeding in a week
  • Patients with histories of gastric surgery
  • Pregnant and lactating women
  • Patients with poor coagulation function
  • Patients diagnosed with gastric cancer

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
cases
Patients who undergo esophagogastroduodenoscopy during 01/12/2016 and 31/12/2016 in the First People's Hospital of Kashgar Region.
Other: Esophagogastroduodenoscopy
Esophagogastroduodenoscopy is an examining method for upper gastrointestinal disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Accuracy, specificity and sensitivity of LCI for diagnosing Hp infection compared with the pathology
Time Frame: one month
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hp infection rate
Time Frame: one month
one month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kashgar 1st People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zou X Guang, First People's Hospital of Kashgar Region

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016A020212007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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