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Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement

Primary Purpose

Gastric Intestinal Metaplasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard endoscopy
High definition endoscopy with Optic Enhancement
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Intestinal Metaplasia

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with dyspeptic symptoms and aged 40 years or older
  • or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
  • or patients with family history of gastric cancer

Exclusion Criteria:

  • presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
  • presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
  • inability to provide informed consent

Sites / Locations

  • Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Standard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature).

High definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia.

Outcomes

Primary Outcome Measures

Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis

Secondary Outcome Measures

Number of biopsies needed in per group

Full Information

First Posted
March 26, 2016
Last Updated
March 30, 2016
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02725034
Brief Title
Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield
Detailed Description
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Standard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
High definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia.
Intervention Type
Device
Intervention Name(s)
Standard endoscopy
Intervention Type
Device
Intervention Name(s)
High definition endoscopy with Optic Enhancement
Primary Outcome Measure Information:
Title
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis
Time Frame
eight months
Title
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis
Time Frame
eight months
Secondary Outcome Measure Information:
Title
Number of biopsies needed in per group
Time Frame
eight months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with dyspeptic symptoms and aged 40 years or older or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis or patients with family history of gastric cancer Exclusion Criteria: presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, PhD. MD.
Phone
18678827666
Email
qiluliyanqing@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD. MD.
Organizational Affiliation
Department of Gastroenterology, Qilu Hospital, Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD. MD.
Phone
18678827666
Ext
82169508
Email
qiluliyanqing@gmail.com

12. IPD Sharing Statement

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Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement

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