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

NCT ID: NCT02806115

Last Updated: 2016-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Intestinal Metaplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

acetic acid-enhanced endoscopy

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

Group Type EXPERIMENTAL

acetic acid-enhanced endoscopy

Intervention Type PROCEDURE

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

Acetic Acid

Intervention Type DRUG

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

endoscope

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acetic acid-enhanced endoscopy

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

Intervention Type PROCEDURE

Acetic Acid

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

Intervention Type DRUG

endoscope

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiuli Zuo

director of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiuli Zuo, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiuli Zuo, PhD

Role: CONTACT

15588818685 ext. 053188369277

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiuli Zuo, PhD

Role: primary

15588818685 ext. 053188369277

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015SDU-QILU-G003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.