Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Stomach Neoplasms Clinical Trial

— IM  

Official title:

Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499576
• Other study ID #: 11-62
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: September 20, 2014
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2014
• Source: Konyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Gastritis, Atrophic
• Metaplasia
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Gastroenterology and Hepatology; Konyang University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Konyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy. 2003 May;35(5):437-45. Review. — View Citation

Lee BE, Kim GH, Park do Y, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	One month after the completion of the study	No
Secondary	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.	up to 1week after the acetic acid chromoendoscopy	Yes