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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00673699
First received: May 5, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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


Condition Intervention
Dyspepsia
 Procedure: Gastric mucosal biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational: Studies in Human Beings Health Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • To determine if endoscope with NBI can detect intestinal metaplasia [ Time Frame: In one week (the time from biopsy till the histology assement) ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Gastric mucosal biopsy during upper gastrointestinal endoscopy


Estimated Enrollment: 70
Study Start Date: May 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Seventy dyspeptic consecutive patients that going upper gastrointestinal endoscopy
 Procedure: Gastric mucosal biopsy
Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia
Other Name: patients ith dyspepsia

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hundred consecutive dyspeptic patients

Criteria

Inclusion Criteria:

  • Dyspepsia

Exclusion Criteria:

  • Pregnancy,
  • Upper gastrointestinal bleeding,
  • Previous gastric operation,
  • Known gastric malignancy'
  • Non cooperative patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673699

Contacts
Contact: Zvi Fireman, MD +972-4-6304384 fireman@hy.health.gov.il
Contact: Yael Kopelman, MD +972-4-6304480 yaelk@hy.health.gov.il

Locations
Israel
Hillel Yaffe Med Ctr Not yet recruiting
Hadera, Israel, 38100
Contact: Zvi Fireman, MD     +972-4-6304384     fireman@hy.health.gov.il    
Sub-Investigator: Yael Kopelman, MD            
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Zvi Fireman, MD Hillel Yaffe Med Ctr
  More Information

Publications:

Responsible Party: Zvi Fireman MD, Head ,Gastroenterology Dept., Zvi Fireman MD, Gastroenterology Dept. Hillel Yaffe Med Ctr
ClinicalTrials.gov Identifier: NCT00673699     History of Changes
Other Study ID Numbers: HY-07/2008
Study First Received: May 5, 2008
Last Updated: May 5, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Hillel Yaffe Medical Center:
NBI
gastroscopy
biopsy
intestinal metaplasia

Additional relevant MeSH terms:
Dyspepsia
Metaplasia
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013