N/A N=126 Screening

Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Stomach Neoplasms · Metaplasia

Bottom Line

View on ClinicalTrials.gov: NCT01499576 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy — 78.5; 94.4; 89.2; 67.1 percentage of lesions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acetic acid chromoendoscopy (Procedure)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Konyang University Hospital
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy	78.5; 94.4; 89.2; 67.1; 94.7; 89.4	—
SECONDARY Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists	0.808	<0.01 sig
SECONDARY Number of Participants With Adverse Events	9; 2	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01499576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.