The Role of Narrow-Band Imaging Endoscopy in Diagnosing Gastric Intestinal Metaplasia

Dyspepsia Clinical Trial

Official title:

Observational: Studies in Human Beings Health Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00673699
• Other study ID #: HY-07/2008
• Status: Not yet recruiting
• Phase: N/A
• First received: May 5, 2008
• Last updated: May 5, 2008
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: May 2008
• Source: Hillel Yaffe Medical Center
• Contact: Zvi Fireman, MD
• Phone: +972-4-6304384
• Email: fireman[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia

Description:

To detect intestinal metaplasia which consider pre malignant condition and use a targeting biopsy in case of suspected intestinal metaplasia which allowed us to better follow-up those patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Dyspepsia

Exclusion Criteria:

• Pregnancy,

• Upper gastrointestinal bleeding,

• Previous gastric operation,

• Known gastric malignancy'

• Non cooperative patients

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Procedure:
• Gastric mucosal biopsy
Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia

Locations

Country	Name	City	State
Israel	Hillel Yaffe Med Ctr	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Hirata M, Tanaka S, Oka S, Kaneko I, Yoshida S, Yoshihara M, Chayama K. Evaluation of microvessels in colorectal tumors by narrow band imaging magnification. Gastrointest Endosc. 2007 Nov;66(5):945-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if endoscope with NBI can detect intestinal metaplasia		In one week (the time from biopsy till the histology assement)	Yes