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

Not Applicable

• Conditions: Gastric Intestinal Metaplasia
• Interventions: Device: High definition endoscopy with Optic Enhancement; Device: Standard endoscopy

• Registration Number: NCT02725034
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-26
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-03-30
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31
• Primary Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	High definition endoscopy with Optic Enhancement	High definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia.
Group 1	Standard endoscopy	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).

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Number of biopsies needed in per group	eight months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China