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

Shandong University

Status and phase: Unknown; Phase 1

Conditions: Gastric Intestinal Metaplasia

Treatments: Device: endoscope; Drug: Acetic Acid; Procedure: acetic acid-enhanced endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02806115

2015SDU-QILU-G003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

acetic acid-enhanced endoscopy

Experimental group

Description:

Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.

Treatment:

Device: endoscope

Drug: Acetic Acid

Procedure: acetic acid-enhanced endoscopy