I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia

Shandong University

Status: Unknown

Conditions: Gastric Intestinal Metaplasia

Treatments: Device: Standard endoscopy; Device: I-scan with magnification

Study type: Interventional

Funder types: Other

Identifiers

NCT02516735

2015SDU-QILU-G07

Details and patient eligibility

About

The purpose of this study is to assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Full 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. I-scan is a novel image-enhanced endoscopy system based on the post processing of reflected light without optical filters. Targeted biopsy protocol based on i-scan with magnification will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from i-scan with magnification targeted biopsies and a standard biopsy protocol and assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Enrollment: 164 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 2 patient groups

Group 1

Experimental group

Description:

I-scan with magnification targeted biopsies for gastric intestinal metapalsia.

Treatment:

Device: I-scan with magnification

Group 2

Active Comparator group

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).

Treatment:

Device: Standard endoscopy