The Value of Black Spots in Diagnosing Gastric Intestinal... | NCT01646528

Studies
The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

NCT01646528

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Jul 20, 2012Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Gastric Intestinal Metaplasia

Interventions

CLE examination for upper gastrointestinal tract

Countries

China

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jun 28, 2012

First Submission Date that Met QC Criteria

Jul 19, 2012

First Posted Date

Jul 20, 2012Estimated

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

Jul 19, 2012

Last Update Posted Date

Jul 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanqing Li, Vice President, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Not provided

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 study aims to:

Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE).
Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.

Detailed Description

Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Consecutive patients for CLE examination			Procedure: CLE examination for upper gastrointestinal tract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLE examination for upper gastrointestinal tract	Procedure	Routine upper GI endoscopy plus targeted CLE examination	Consecutive patients for CLE examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of black spots in diagnosis of gastric intestinal metaplasia		up to six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney.

Exclusion Criteria:

Patients who are allergic to fluorescein sodium
Patients who are unwilling to sign or give the informed consent form
Patients with impaired cardiac, liver or renal function
Patients with coagulopathy
Patients with pregnancy or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients without any disease of heart, liver or kidney.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing Li, MD, PhD	Contact	86-531-8216923	82169508	liyanqing@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD, PhD	Department of Gastroenterology, Qilu Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China