Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetic acid spraying | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetic acid chromoendoscopy | Procedure | Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | 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 %. | 3 months after the completion of the study (a pathologist reviewed all the biopsy slide) |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists | 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. | One month after the completion of the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyung Ho Song, M.D., Master | Konyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology; Konyang University Hospital | Daejeon | 302-718 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12701018 | Background | Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy. 2003 May;35(5):437-45. doi: 10.1055/s-2003-38766. No abstract available. | |
| 20731830 | Background | Lee BE, Kim GH, Park DY, Kim DH, Jeon TY, Park SB, You HS, Ryu DY, Kim DU, Song GA. Acetic acid-indigo carmine chromoendoscopy for delineating early gastric cancers: its usefulness according to histological type. BMC Gastroenterol. 2010 Aug 23;10:97. doi: 10.1186/1471-230X-10-97. |
| Label | URL |
|---|---|
| Konyang University Hospital, Web page | View source |
Not provided
Not provided
Dates of the recruitment period: From Oct 2011 to Mar 2012. Recruiting institute: Konyang University Hospital, via the outpatient clinic or General Examination Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acetic Acid Spraying | Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acetic Acid Spraying | Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | 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 %. | Number | percentage of lesions | 3 months after the completion of the study (a pathologist reviewed all the biopsy slide) | lesions | Participants |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetic Acid Spraying | Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epigastric discomfort | Gastrointestinal disorders |
Concomitant comparison with methylene blue chromoendoscopy was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyung Ho SONG, Assistnat Professor of Konyang University | Konyang University Hospital | postit2@daum.net, postit@kyuh.ac.kr |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D008679 | Metaplasia |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Participants With Adverse Events |
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. |
| up to 1week after the acetic acid chromoendoscopy |
| 10894575 | Background | Cassaro M, Rugge M, Gutierrez O, Leandro G, Graham DY, Genta RM. Topographic patterns of intestinal metaplasia and gastric cancer. Am J Gastroenterol. 2000 Jun;95(6):1431-8. doi: 10.1111/j.1572-0241.2000.02074.x. |
| 27515128 | Derived | Song KH, Hwang JA, Kim SM, Ko HS, Kang MK, Ryu KH, Koo HS, Lee TH, Huh KC, Choi YW, Kang YW. Acetic acid chromoendoscopy for determining the extent of gastric intestinal metaplasia. Gastrointest Endosc. 2017 Feb;85(2):349-356. doi: 10.1016/j.gie.2016.07.064. Epub 2016 Aug 8. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| lesions |
|
|
|
| Secondary | Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists | 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 | Kappa index of agreement | One month after the completion of the study | lesions | Participants |
|
|
|
|
| Secondary | Number of Participants With Adverse Events | 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. | Number | participants | up to 1week after the acetic acid chromoendoscopy |
|
|
|
|
| 0 |
| 105 |
| 11 |
| 105 |
| Odynophagia | Gastrointestinal disorders |
|
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |