Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Not Applicable

Completed

• Conditions: Stomach Neoplasms; Metaplasia
• Interventions: Procedure: Acetic acid chromoendoscopy

• Registration Number: NCT01499576
• Lead Sponsor: Konyang University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Results First Submitted: 2014-05-19
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-20
• Last Update Submitted: 2014-09-20
• Results First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acetic acid spraying	Acetic acid chromoendoscopy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Department of Gastroenterology and Hepatology; Konyang University Hospital; 🇰🇷 Daejeon, Korea, Republic of