Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499576
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Information provided by (Responsible Party):
Kyung Ho Song, MD, Konyang University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Metaplasia Procedure: Acetic acid chromoendoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
Study Start Date : November 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acetic acid spraying Procedure: Acetic acid chromoendoscopy
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

Primary Outcome Measures :
  1. 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 %.

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499576

Korea, Republic of
Department of Gastroenterology and Hepatology; Konyang University Hospital
Daejeon, Korea, Republic of, 302-718
Sponsors and Collaborators
Konyang University Hospital
Principal Investigator: Kyung Ho Song, M.D., Master Konyang University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kyung Ho Song, MD, Assistant Professor, Konyang University Hospital Identifier: NCT01499576     History of Changes
Other Study ID Numbers: 11-62
First Posted: December 26, 2011    Key Record Dates
Results First Posted: September 26, 2014
Last Update Posted: September 26, 2014
Last Verified: September 2014

Keywords provided by Kyung Ho Song, MD, Konyang University Hospital:
Mass Screening
Endoscopy, Gastrointestinal
Stomach Neoplasms
Acetic acid

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents