Trial Outcomes & Findings for Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (NCT NCT01499576)

Results Overview

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 %.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

126 participants

Primary outcome timeframe

3 months after the completion of the study (a pathologist reviewed all the biopsy slide)

Results posted on

2014-09-26

Participant Flow

Dates of the recruitment period: From Oct 2011 to Mar 2012. Recruiting institute: Konyang University Hospital, via the outpatient clinic or General Examination Center.

Participant milestones

Participant milestones
Measure	Acetic Acid Spraying Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Overall Study STARTED	126
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Acetic Acid Spraying Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Overall Study Physician Decision	12
Overall Study Withdrawal by Subject	9

Baseline Characteristics

Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetic Acid Spraying n=105 Participants Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	96 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 9.3 • n=93 Participants
Sex: Female, Male Female	52 Participants n=93 Participants
Sex: Female, Male Male	53 Participants n=93 Participants
Region of Enrollment Korea, Republic of	105 participants n=93 Participants

PRIMARY outcome

Timeframe: 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 %.

Outcome measures

Outcome measures
Measure	Acetic Acid Spraying n=525 lesions Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Overall Sensitivity	78.5 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Overall Specificity	94.4 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Overall Accuracy	89.2 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Body Sensitivity	67.1 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Body Specificity	94.7 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Body Accuracy	89.4 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Antrum Sensitivity	80.9 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Antrum Specificity	93.6 percentage of lesions
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy Antrum Accuracy	88.4 percentage of lesions

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acetic Acid Spraying n=505 lesions Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists	0.808 Kappa index of agreement

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acetic Acid Spraying n=105 Participants Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Number of Participants With Adverse Events Epigastric discomfort	9 participants
Number of Participants With Adverse Events Neck discomfort	2 participants

Adverse Events

Acetic Acid Spraying

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acetic Acid Spraying n=105 participants at risk Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
Gastrointestinal disorders Epigastric discomfort	8.6% 9/105
Gastrointestinal disorders Odynophagia	1.9% 2/105

Additional Information

Dr. Kyung Ho SONG, Assistnat Professor of Konyang University

Konyang University Hospital

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place