Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyung Ho Song, MD, Konyang University Hospital
ClinicalTrials.gov Identifier:
NCT01499576
First received: December 20, 2011
Last updated: September 20, 2014
Last verified: September 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: Kyung Ho Song, MD, Assistant Professor, Konyang University Hospital
ClinicalTrials.gov Identifier: NCT01499576     History of Changes
Other Study ID Numbers: 11-62
Study First Received: December 20, 2011
Results First Received: May 19, 2014
Last Updated: September 20, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Konyang University Hospital:
Mass Screening
Endoscopy, Gastrointestinal
Stomach Neoplasms
Metaplasia
Diagnosis
Acetic acid
Chromoendoscopy

Additional relevant MeSH terms:
Gastritis, Atrophic
Metaplasia
Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Pathologic Processes
Stomach Diseases
Retinol acetate
Adjuvants, Immunologic
Anticarcinogenic Agents
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014