The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia

Phase 1

• Conditions: Gastric Intestinal Metaplasia
• Interventions: Procedure: acetic acid-enhanced endoscopy; Drug: Acetic Acid; Device: endoscope

• Registration Number: NCT02806115
• Lead Sponsor: Shandong University

Brief Summary

Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called "severe whitening" and "delayed fading", and investigators realized that GIM could possibly be diagnosed by using these differences.The aim of this prospective study was to investigate the efficacy of "severe whitening" and "delayed fading" for diagnosing GIM.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-05
• Study First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-15
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20
• Primary Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• long-lasting upper gastrointestinal symptoms (>15 years)
• atrophic gastritis or GIM identified at surveillance endoscopy

Exclusion Criteria

• presence of advanced adenocarcinoma in the stomach
• presence of acute gastrointestinal bleeding
• presence of coagulopathy, uncontrolled impaired renal or liver disease
• presence of pregnancy or lactation
• presence of allergy to acetic acid
• age younger than 18 years or older than 80 years
• inability to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acetic acid-enhanced endoscopy	acetic acid-enhanced endoscopy	Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
acetic acid-enhanced endoscopy	Acetic Acid	Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
acetic acid-enhanced endoscopy	endoscope	Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.

Primary Outcome Measures

Name	Time	Method
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia	6 months
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia	6 months

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China