Gastric Intestinal Metaplasia
Conditions
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.
Interventions
DEVICEStandard endoscopy
DEVICEHigh definition endoscopy with Optic Enhancement
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of biopsies needed in per group | eight months |
Countries
China
Contacts
Primary ContactYanqing Li, PhD. MD.
Outcome results
None listed