Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement
1 other identifier
interventional
160
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedMarch 31, 2016
March 1, 2016
7 months
March 26, 2016
March 30, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
eight months
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
eight months
Secondary Outcomes (1)
Number of biopsies needed in per group
eight months
Study Arms (2)
Group 1
ACTIVE COMPARATORStandard 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).
Group 2
EXPERIMENTALHigh definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Study Officials
- STUDY DIRECTOR
Yanqing Li, PhD. MD.
Department of Gastroenterology, Qilu Hospital, Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
March 26, 2016
First Posted
March 31, 2016
Study Start
January 1, 2016
Primary Completion
August 1, 2016
Last Updated
March 31, 2016
Record last verified: 2016-03