Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Overview

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.

Full Title of Study: “Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • Procedure: Acetic acid chromoendoscopy
    • Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

Arms, Groups and Cohorts

  • Experimental: Acetic acid spraying

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Konyang University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kyung Ho Song, MD, Assistant Professor – Konyang University Hospital
  • Overall Official(s)
    • Kyung Ho Song, M.D., Master, Principal Investigator, Konyang University

References

Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy. 2003 May;35(5):437-45. doi: 10.1055/s-2003-38766. No abstract available.

Lee BE, Kim GH, Park DY, Kim DH, Jeon TY, Park SB, You HS, Ryu DY, Kim DU, Song GA. Acetic acid-indigo carmine chromoendoscopy for delineating early gastric cancers: its usefulness according to histological type. BMC Gastroenterol. 2010 Aug 23;10:97. doi: 10.1186/1471-230X-10-97.

Cassaro M, Rugge M, Gutierrez O, Leandro G, Graham DY, Genta RM. Topographic patterns of intestinal metaplasia and gastric cancer. Am J Gastroenterol. 2000 Jun;95(6):1431-8. doi: 10.1111/j.1572-0241.2000.02074.x.

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