Clinical trial NCT01499576: Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia
Official title: Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Metaplasia
Keywords: Mass Screening
Endoscopy, Gastrointestinal
Stomach Neoplasms
Metaplasia
Diagnosis
Acetic acid
Chromoendoscopy
Lead sponsor: Konyang University Hospital
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 126
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
timeFrame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
Secondary outcomes:
measure: Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
timeFrame: One month after the completion of the study
measure: Number of Participants With Adverse Events
timeFrame: up to 1week after the acetic acid chromoendoscopy
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Department of Gastroenterology and Hepatology; Konyang University Hospital
Study officials:
affiliation: Konyang University
name: Kyung Ho Song, M.D., Master
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.