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

Shandong University160 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

160

Conditions

Gastric Intestinal Metaplasia

Interventions

Standard endoscopyDEVICE

High definition endoscopy with Optic EnhancementDEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

Number of biopsies needed in per group

Time frame: eight months

Central Contacts

Yanqing Li, PhD. MD.

CONTACT

18678827666 qiluliyanqing@gmail.com

Data from ClinicalTrials.gov

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