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Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499576
First Posted: December 26, 2011
Last Update Posted: September 26, 2014
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.
Information provided by (Responsible Party):
Kyung Ho Song, MD, Konyang University Hospital
  Purpose
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 Intervention
Stomach Neoplasms Metaplasia Procedure: Acetic acid chromoendoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Resource links provided by NLM:


Further study details as provided by Kyung Ho Song, MD, Konyang University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


  • 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.


Enrollment: 126
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetic acid spraying Procedure: Acetic acid chromoendoscopy
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01499576


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyung Ho Song, MD, Assistant Professor, Konyang University Hospital
ClinicalTrials.gov Identifier: NCT01499576     History of Changes
Other Study ID Numbers: 11-62
First Submitted: December 20, 2011
First Posted: December 26, 2011
Results First Submitted: May 19, 2014
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
Metaplasia
Diagnosis
Acetic acid
Chromoendoscopy

Additional relevant MeSH terms:
Stomach Neoplasms
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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