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Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia (IM)

Primary Purpose

Stomach Neoplasms, Metaplasia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acetic acid chromoendoscopy
Sponsored by
Konyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stomach Neoplasms focused on measuring Mass Screening, Endoscopy, Gastrointestinal, Stomach Neoplasms, Metaplasia, Diagnosis, Acetic acid, Chromoendoscopy

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Gastroenterology and Hepatology; Konyang University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acetic acid spraying

Arm Description

Outcomes

Primary Outcome Measures

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 %.

Secondary Outcome Measures

Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
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
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.

Full Information

First Posted
December 20, 2011
Last Updated
September 20, 2014
Sponsor
Konyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01499576
Brief Title
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia
Acronym
IM
Official Title
Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konyang University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Metaplasia
Keywords
Mass Screening, Endoscopy, Gastrointestinal, Stomach Neoplasms, Metaplasia, Diagnosis, Acetic acid, Chromoendoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetic acid spraying
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Acetic acid chromoendoscopy
Intervention Description
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
Primary Outcome Measure Information:
Title
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Description
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 %.
Time Frame
3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
Secondary Outcome Measure Information:
Title
Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
Description
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.
Time Frame
One month after the completion of the study
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
up to 1week after the acetic acid chromoendoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Ho Song, M.D., Master
Organizational Affiliation
Konyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology; Konyang University Hospital
City
Daejeon
ZIP/Postal Code
302-718
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
12701018
Citation
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.
Results Reference
background
PubMed Identifier
20731830
Citation
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.
Results Reference
background
PubMed Identifier
10894575
Citation
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.
Results Reference
background
PubMed Identifier
27515128
Citation
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.
Results Reference
derived
Links:
URL
http://www.kyuh.co.kr
Description
Konyang University Hospital, Web page

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Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

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