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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02806115
Enrollment
100
Registered
2016-06-20
Start date
2016-06-30
Completion date
Unknown
Last updated
2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Intestinal Metaplasia

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.

Interventions

PROCEDUREacetic acid-enhanced endoscopy

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

The concentration of acetic acid used in this study is 1.5%.

DEVICEendoscope

This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
accuracy of severe whitening for diagnosing gastric intestinal metaplasia6 months
accuracy of delayed fading for diagnosing gastric intestinal metaplasia6 months

Countries

China

Contacts

Primary ContactXiuli Zuo, PhD
zuoxiuli@sina.com15588818685

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026