Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)
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:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia|
- 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) ] [ Designated as safety issue: No ]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 %.
- Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists [ Time Frame: One month after the completion of the study ] [ Designated as safety issue: No ]
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.
- Number of Participants With Adverse Events [ Time Frame: up to 1week after the acetic acid chromoendoscopy ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Acetic acid spraying||
Procedure: Acetic acid chromoendoscopy
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499576
|Korea, Republic of|
|Department of Gastroenterology and Hepatology; Konyang University Hospital|
|Daejeon, Korea, Republic of, 302-718|
|Principal Investigator:||Kyung Ho Song, M.D., Master||Konyang University|