The Role of Narrow-Band Imaging Endoscopy in Diagnosing G... | NCT00673699

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

NCT00673699

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

May 7, 2008Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Dyspepsia

Interventions

Gastric mucosal biopsy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jan 2009Estimated

Completion Date

Feb 2009Estimated

First Submitted Date

May 5, 2008

First Submission Date that Met QC Criteria

May 5, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2008

Last Update Posted Date

May 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Seventy dyspeptic consecutive patients that going upper gastrointestinal endoscopy	Procedure: Gastric mucosal biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric mucosal biopsy	Procedure	Using upper gastrointestinal endoscopy with targeting biopsy in patients with dyspepsia	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if endoscope with NBI can detect intestinal metaplasia		In one week (the time from biopsy till the histology assement)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dyspepsia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Hundred consecutive dyspeptic patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zvi Fireman, MD	Contact	+972-4-6304384		fireman@hy.health.gov.il
Yael Kopelman, MD	Contact	+972-4-6304480		yaelk@hy.health.gov.il

Overall Officials

Name	Affiliation	Role
Zvi Fireman, MD	Hillel Yaffe Med Ctr	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Med Ctr		Hadera		38100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17963882	Background	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.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms