Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)
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|ClinicalTrials.gov Identifier: NCT01499576|
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Metaplasia||Procedure: Acetic acid chromoendoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||April 2012|
|Experimental: Acetic acid spraying||
Procedure: Acetic acid chromoendoscopy
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
- 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 %.
- Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists [ Time Frame: One month after the completion of the study ]
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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|