New Classification of Stomach Using Probe-based Confocal... | NCT01896310

Studies
New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

NCT01896310

Sponsor

Shandong University

Status

Completed

Last Update Posted

May 13, 2014Estimated

Enrollment

272Actual

Phase

Not provided

Conditions

Gastric Cancer
Intestinal Metaplasia
Atrophic Gastritis
Inflammation

Interventions

probe-based confocal laser endomicroscopy

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

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jun 28, 2013

First Submission Date that Met QC Criteria

Jul 5, 2013

First Posted Date

Jul 11, 2013Estimated

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 9, 2014

Last Update Posted Date

May 13, 2014Estimated

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 aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Detailed Description

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

272Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pCLE examination		patients will be prospectively recruited and examined first with high-definition endoscopy (EG-2990i, Pentax, Japan) followed by probe-based confocal laser endomicroscopy	Device: probe-based confocal laser endomicroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probe-based confocal laser endomicroscopy	Device	all patients will receive pCLE examination	pCLE examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic accuracy of the new classification system	Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of the new classification of gastric pit patterns and vessel architecture using probe-based confocal laser endomicroscopy	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for pCLE examination
aged between 18 and 80 years old

Exclusion Criteria:

Esophageal, gastric or duodenal cancer or other malignancy
History of upper GI tract surgery
Coagulopathy or bleeding disorders
Allergy to fluorescein sodium
Pregnant or breast-feeding (for females)
Impaired renal function

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

Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD.PhD.	Qilu Hospital of Shandong University	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D005757	Gastritis, Atrophic
D007249	Inflammation

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided