Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

NCT01499576 | Completed Results DMC

• 1 other identifier: 11-62
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms; Metaplasia

Keywords

Mass Screening; Endoscopy, Gastrointestinal; Stomach Neoplasms; Metaplasia; Diagnosis; Acetic acid; Chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy

  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 %.

  3 months after the completion of the study (a pathologist reviewed all the biopsy slide)

Secondary Outcomes (2)

• Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists

  One month after the completion of the study

• Number of Participants With Adverse Events

  up to 1week after the acetic acid chromoendoscopy

Study Arms (1)

Acetic acid spraying

EXPERIMENTAL

Procedure: Acetic acid chromoendoscopy

Interventions

Acetic acid chromoendoscopy PROCEDURE

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

Acetic acid spraying

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person who undergo gastroduodenoscopy
• Person who visit Konyang University Hospital

You may not qualify if:

• Bleeding diathesis
• History of stomach neoplasms
• History of upper gastrointestinal surgery

Sponsors & Collaborators

• Konyang University Hospital: lead

Study Sites (1)

Department of Gastroenterology and Hepatology; Konyang University Hospital

Daejeon, 302-718, South Korea

Location

Related Publications (4)

• 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.

  PMID: 12701018 BACKGROUND

• 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.

  PMID: 20731830 BACKGROUND

• 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.

  PMID: 10894575 BACKGROUND

• 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.

  PMID: 27515128 DERIVED

Related Links

• Konyang University Hospital, Web page

MeSH Terms

Conditions

Stomach Neoplasms; Metaplasia; Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Concomitant comparison with methylene blue chromoendoscopy was not performed.

Results Point of Contact

• Title: Dr. Kyung Ho SONG, Assistnat Professor of Konyang University
• Organization: Konyang University Hospital

postit2@daum.net, postit@kyuh.ac.kr

Study Officials

• Kyung Ho Song, M.D., Master

  Konyang University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 26, 2014
• Results First Posted: September 26, 2014

Record last verified: 2014-09

Locations

KR (1)