Magnified Intelligence Chromoendoscopy Plus Probe-based Confocal Laser Endomicroscopy for Gastric Intestinal Metaplasia Diagnosis

June 9, 2014 updated by: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial

Research Question:

Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?

Objective:

To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia.

Hypothesis:

Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal metaplasia.

Research design:

Diagnostic study

Sample size:

The investigators follow the population in recent study from Imraporn et al.: Validity of magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)

Data analysis:

Confocal Barrett's esophagus classification was used to evaluate agreement of confocal endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold standard for diagnosis, and reported as sensitivity, specificity, positive predictive value, negative predictive value and accuracy of these criteria.

Expected Benefit and Application:

The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in order to improve the quality of GIM/dysplasia/early gastric cancer detection and then decrease the mortality rate from gastric cancer in the future.

Study Overview

Status

Status

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

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

Background and Rationale:

Gastric cancer is the second leading cause of cancer related death in the world in recently data. The incidence and mortality rate is predominant in East Asia. Usually, gastric cancer is asymptomatic in early stage; therefore; most patients is in the advanced stage and incurable at diagnosis. The pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. Moreover, the direction of pathway is irreversible beyond dysplasia. The equipment and/or procedure which can detect gastric dysplasia are very beneficial.

The recent study, Imraporn B et al., showed that narrow-banded imaging with magnification (NBI-ME) had a better sensitivity for gastric intestinal metaplasia (GIM) detection than a standard white light endoscopy (73% VS. 13%) and could detect two early gastric cancer from tissue pathology in 1-year follow-up cohort study. However, NBI-ME cannot differentiate among GIM, dysplasia and gastric cancer.

Confocal endomicroscope is a powerful instrument for performing high-resolution (x1,000 time) imaging to enable real-time histology and/or optical biopsy at the time of endoscopic examination(in vivo histology).Fluorescein, is a slightly acidic and hydrophilic dye, will be used as staining substance via IV administration. The fluorescein established a stable distribution throughout surface epithelial cells, which is regular columnar epithelium with round gland openings and cobblestone pattern; the connective tissue matrix of lamina propria; blood vessels, which are regular shape visible in the deeper mucosa; and red blood cells.It is not highly miscible with mucins, hence, mucins in goblet cells, which indicated GIM, will appear dark.

Because GIM is characterized by the diminutive lesions or microscopic abnormalities amidst large fields of diffuse disease, biopsy targeting and adequate sampling can be difficult and time consuming. Therefore, the instant resection with confocal microendoscope is not possible.

Consequently, the patient must be diagnosed GIM via a targeted NBI-ME biopsy first. And then endoscopic mucosal resection (EMR) via confocal endomicrosocpe is possible to be the complete therapeutic treatment for early gastric cancer within the same session at the suspected area of gastric dysplasia or neoplasia.

However, no study about confocal endomicroscope related early detection of gastric cancer was observed.

In this study, we must apply the endomicroscope's criteria from confocal Barrett's esophagus classification to indicate gastric dysplasia or neoplasia. The aim of this study is to evaluate the feasibility of confocal endomicroscopy to diagnose gastric intestinal metaplasia.

Review of related literature:

Confocal endomicroscope is available in 2005. The difference between white light endoscope and confocal endomicroscope.

Nowadays, a point-scanning fiber-optic fluorescein confocal endomicroscope for evaluate cellular morphology of the upper- and the lower-GI tract is possible. However, the improvement of diagnostic yield is evaluated in only Barrett's esophagus, colorectal cancer, detecting Helicobacter pylori. There is no exactly study about early detection of gastric cancer with confocal endomicroscope. Investigator use the confocal Barrett's esophagus classification to predict the area of dysplasia or neoplasia in stomach.

Assumption:

All patients have to undergo a targeted NBI-ME biopsy and never be treated as gastric cancer before.

Key Words:

Confocal endomicroscope Gastric intestinal metaplasia

Operational definition:

Gastric intestinal metaplasia/dysplasia/neoplasim is base on the updated Sydney classification.

Research methodology:

Population and Sample Target and sample population: The patients who were diagnosed gastric intestinal metaplasia (GIM) in the past 2 years in KCMH.

Observation and Measurement:

Collect the geographic data by interview and review the outpatient record. Evaluate the tissue pathology by one pathologist

Methodology:

  1. All patients had informed the consent.
  2. Take the history, physical examination and then fill in the record form

  3. Set confocal endomicroscopy

    • 10% Fluorescein sodium 10 ml was injected intravenously.
    • 2.5-5 milligrams of intravenous midazolam and 10 milligrams of hyoscine were injected to sedate and decrease bowel movement for easier and complete visualization.
    • Simethicone solution was rinsed to reduce mucous and gas bubble in the stomach.
    • FICE was used to identify the area of suspected GIM.
    • Confocal endomicroscopy was performed and targeted to the suspected area. One snapshot images was recorded at the area of suspected and record the criteria of diagnosis GIM. Endoscopic resection was done at the suspected area.
    • DVD was recorded during the endoscopy.
  4. Record the duration and complication of the procedure
  5. Send the tissues to one clinically-blinded GI pathologist
  6. Compare the pathology report and endoscopic finding
  7. Report the result

Data collection:

All data are processed and recorded by one physician.

Ethical considerations:

There is not a clearly evidence about the serious side effect of fluorescein injection. If the patients had side effects during the research, the procedure will be terminated and the patients will be take care from KCMH staff.

Limitation:

This is a novel diagnostic tool to analyze living cells during endoscopy, especially for gastric intestinal metaplasia (GIM). There is not a standard criterion about confocal endomicroscopy finding in GIM. Investigator have to apply from Barrett's esophagus criteria and learn about criteria in GIM and gastric cancer.

Obstacles and strategies to solve the problems:

Because this is the study which base on the population from previous study by Imraporn et al., maybe some patients will loss follow up. The strategies to solve the problems are

  1. Early call back to make an appointment
  2. Collect new patients from the database of pathology department, KCMH

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.
Interventional

Enrollment (Actual)

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.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Thailand
      • Bangkok, Thailand, 10330
        • Rapat Pittayanon

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-80 year-old
  2. All patients were diagnosed GIM in the past 2 years.
  3. All patients have to sign the consent form

Exclusion Criteria:

  1. Previous gastric surgery including gastrectomy and bypass surgery
  2. Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
  3. Pregnanacy
  4. History of fluorescein allergy

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
EXPERIMENTAL: Gastric intestinal metaplasia
Device: Confocol laser endomicroscopy
Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.
PLACEBO_COMPARATOR: Normal
Device: Confocol laser endomicroscopy
Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.

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
Measure Description
Time Frame
The feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia
Time Frame: Up to 2 years
If GIM can be detected properly, early gastric cancer(EGC) will be in early recognition. EGC can be cured by endoscopic resection and then the mortality rate from gastric cancer will be decrease.
Up to 2 years

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.
King Chulalongkorn Memorial Hospital

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

Helpful Links

Study record dates

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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.
April 1, 2010

Primary Completion (ACTUAL)

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.
December 1, 2011

Study Completion (ACTUAL)

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.
February 1, 2012

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 5, 2011

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.
December 8, 2011

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.
December 9, 2011

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.
June 11, 2014

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.
June 9, 2014

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.
June 1, 2014

More Information

Terms related to this study

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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.
  • RP002

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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