Metaplasia, Stomach Neoplasms
Conditions
Keywords
Mass Screening, Endoscopy, Gastrointestinal, Stomach Neoplasms, Metaplasia, Diagnosis, Acetic acid, Chromoendoscopy
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.
Interventions
PROCEDUREAcetic acid chromoendoscopy
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
Sponsors
Konyang University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists | 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 | 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. |
Countries
South Korea
Participant flow
Recruitment details
Dates of the recruitment period: From Oct 2011 to Mar 2012. Recruiting institute: Konyang University Hospital, via the outpatient clinic or General Examination Center.
Participants by arm
| Arm | Count |
|---|---|
| Acetic Acid Spraying Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 12 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Acetic Acid Spraying |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants |
| Age, Continuous | 50.9 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment Korea, Republic of | 105 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
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 %.
Time frame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Overall Sensitivity | 78.5 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Overall Specificity | 94.4 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Overall Accuracy | 89.2 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Body Sensitivity | 67.1 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Body Specificity | 94.7 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Body Accuracy | 89.4 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Antrum Sensitivity | 80.9 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Antrum Specificity | 93.6 percentage of lesions |
| Acetic Acid Spraying | Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy | Antrum Accuracy | 88.4 percentage of 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.
Time frame: One month after the completion of the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acetic Acid Spraying | Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists | 0.808 Kappa index of agreement |
p-value: <0.01Kappa index of agreement
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.
Time frame: up to 1week after the acetic acid chromoendoscopy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acetic Acid Spraying | Number of Participants With Adverse Events | Epigastric discomfort | 9 participants |
| Acetic Acid Spraying | Number of Participants With Adverse Events | Neck discomfort | 2 participants |