N/A
Completed N=126
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia
Gastric Cancer · Metaplasia
Source: ClinicalTrials.gov NCT01499576 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy — 78.5; 94.4; 89.2; 67.1 percentage of lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy |
78.5; 94.4; 89.2; 67.1; 94.7; 89.4 | — |
| SECONDARY Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists |
0.808 | <0.01 sig |
| SECONDARY Number of Participants With Adverse Events |
9; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01499576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.