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

Primary Purpose

Gastric Intestinal Metaplasia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
acetic acid-enhanced endoscopy
Acetic Acid
endoscope
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Intestinal Metaplasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Qilu Hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

acetic acid-enhanced endoscopy

Arm Description

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

Outcomes

Primary Outcome Measures

accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia

Secondary Outcome Measures

Full Information

First Posted
June 5, 2016
Last Updated
June 15, 2016
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02806115
Brief Title
The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acetic acid-enhanced endoscopy
Arm Type
Experimental
Arm Description
Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
Intervention Type
Procedure
Intervention Name(s)
acetic acid-enhanced endoscopy
Intervention Description
Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
Intervention Type
Drug
Intervention Name(s)
Acetic Acid
Intervention Description
The concentration of acetic acid used in this study is 1.5%.
Intervention Type
Device
Intervention Name(s)
endoscope
Intervention Description
This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).
Primary Outcome Measure Information:
Title
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia
Time Frame
6 months
Title
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, PhD
Phone
15588818685
Ext
053188369277
Email
zuoxiuli@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, PhD
Phone
15588818685
Ext
053188369277
Email
zuoxiuli@sina.com
First Name & Middle Initial & Last Name & Degree
Lidong Xu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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