NCT00673699

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

May 5, 2008

Last Update Submit

May 5, 2008

Conditions

Dyspepsia

Keywords

NBIgastroscopybiopsyintestinal metaplasia

Outcome Measures

Primary Outcomes (1)

  • To determine if endoscope with NBI can detect intestinal metaplasia

    In one week (the time from biopsy till the histology assement)

Study Arms (1)

A

Seventy dyspeptic consecutive patients that going upper gastrointestinal endoscopy

Procedure: Gastric mucosal biopsy

Interventions

Gastric mucosal biopsyPROCEDURE

Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia

Also known as: patients ith dyspepsia
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hundred consecutive dyspeptic patients

You may qualify if:

  • Dyspepsia

You may not qualify if:

  • Pregnancy,
  • Upper gastrointestinal bleeding,
  • Previous gastric operation,
  • Known gastric malignancy'
  • Non cooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Med Ctr

Hadera, 38100, Israel

Location

Related 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. doi: 10.1016/j.gie.2007.05.053.

    PMID: 17963882BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gastric mucosal biopsy during upper gastrointestinal endoscopy

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zvi Fireman, MD

    Hillel Yaffe Med Ctr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zvi Fireman, MD

CONTACT

+972-4-6304384fireman@hy.health.gov.il

Yael Kopelman, MD

CONTACT

+972-4-6304480yaelk@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

IL(1)