Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Konyang University Hospital
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Time Frame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
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 %.
Secondary Outcomes
- Number of Participants With Adverse Events(up to 1week after the acetic acid chromoendoscopy)
- Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists(One month after the completion of the study)
Investigators
Kyung Ho Song, MD
Assistant Professor
Konyang University Hospital