The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 5, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedJune 20, 2016
June 1, 2016
2 months
June 5, 2016
June 15, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia
6 months
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia
6 months
Study Arms (1)
acetic acid-enhanced endoscopy
EXPERIMENTALAcetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
Interventions
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%.
This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).
Eligibility Criteria
You may qualify if:
- long-lasting upper gastrointestinal symptoms (\>15 years)
- atrophic gastritis or GIM identified at surveillance endoscopy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuli Zuo, PhD
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of Qilu Hospital
Study Record Dates
First Submitted
June 5, 2016
First Posted
June 20, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2016
Last Updated
June 20, 2016
Record last verified: 2016-06