Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)

September 20, 2014 updated by: Kyung Ho Song, MD, Konyang University Hospital

Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 302-718
        • Department of Gastroenterology and Hepatology; Konyang University Hospital

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

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Person who undergo gastroduodenoscopy
  • Person who visit Konyang University Hospital

Exclusion Criteria:

  • Bleeding diathesis
  • History of stomach neoplasms
  • History of upper gastrointestinal surgery

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: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acetic acid spraying
Procedure: Acetic acid chromoendoscopy
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Time Frame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.
3 months after the completion of the study (a pathologist reviewed all the biopsy slide)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
Time Frame: One month after the completion of the study

The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.

We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.
One month after the completion of the study
Number of Participants With Adverse Events
Time Frame: up to 1week after the acetic acid chromoendoscopy
Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.
up to 1week after the acetic acid chromoendoscopy

Collaborators and Investigators

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

Sponsor

Konyang University Hospital

Investigators

  • Principal Investigator: Kyung Ho Song, M.D., Master, Konyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (ESTIMATE)

December 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 20, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-62

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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