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

June 15, 2016 updated by: Xiuli Zuo, Shandong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiuli Zuo, PhD
  • Phone Number: 053188369277 15588818685
  • Email: zuoxiuli@sina.com

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital, Shandong University
        • Contact:
        • Sub-Investigator:
          • Lidong Xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acetic acid-enhanced endoscopy
Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
Procedure: acetic acid-enhanced endoscopy
Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
Drug: Acetic Acid
The concentration of acetic acid used in this study is 1.5%.
Device: endoscope
This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia
Time Frame: 6 months
6 months
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Xiuli Zuo, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

June 5, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015SDU-QILU-G003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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