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Clinical Trials/NCT01499576
NCT01499576CompletedNot Applicable

Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Konyang University Hospital2 sites in 1 country126 target enrollmentStarted: November 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kyung Ho Song, MD

Assistant Professor

Konyang University Hospital

Study Sites (2)

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