Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Study Overview
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Brief Summary
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The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.

Official Title
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Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Conditions
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Stomach Neoplasms, Metaplasia

Intervention / Treatment
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* Procedure: Acetic acid chromoendoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person who undergo gastroduodenoscopy Person who visit Konyang University Hospital Exclusion Criteria: Bleeding diathesis History of stomach neoplasms History of upper gastrointestinal surgery

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetic acid spraying<br> | Procedure: Acetic acid chromoendoscopy<br>* Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %. | 3 months after the completion of the study (a pathologist reviewed all the biopsy slide) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists | The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently. We calculate the Kappa index of agreement for the acetic acid chromoendoscopy. | One month after the completion of the study | 
| Number of Participants With Adverse Events | Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later. | up to 1week after the acetic acid chromoendoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass Screening, Endoscopy, Gastrointestinal, Stomach Neoplasms, Metaplasia, Diagnosis, Acetic acid, Chromoendoscopy