Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

NCT ID: NCT01499576

Last Updated: 2014-09-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stomach Neoplasms Metaplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Acetic acid spraying

Group Type EXPERIMENTAL

Acetic acid chromoendoscopy

Intervention Type PROCEDURE

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

Interventions

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Acetic acid chromoendoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyung Ho Song, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Ho Song, M.D., Master

Role: PRINCIPAL_INVESTIGATOR

Konyang University

Locations

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Department of Gastroenterology and Hepatology; Konyang University Hospital

Daejeon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 12701018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20731830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10894575 (View on PubMed)

Song KH, Hwang JA, Kim SM, Ko HS, Kang MK, Ryu KH, Koo HS, Lee TH, Huh KC, Choi YW, Kang YW. Acetic acid chromoendoscopy for determining the extent of gastric intestinal metaplasia. Gastrointest Endosc. 2017 Feb;85(2):349-356. doi: 10.1016/j.gie.2016.07.064. Epub 2016 Aug 8.

Reference Type DERIVED
PMID: 27515128 (View on PubMed)

Related Links

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http://www.kyuh.co.kr

Konyang University Hospital, Web page

Other Identifiers

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11-62

Identifier Type: -

Identifier Source: org_study_id

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