NCT02516735

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

I-scan With Magnification Targeted Biopsies Compared With a Standard Biopsy Protocol for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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. 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.

Conditions

• Gastric Intestinal Metaplasia

Interventions

Type	Name	Description
DEVICE	I-scan with magnification
DEVICE	Standard endoscopy

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-11-01
• First posted: 2015-08-06
• Last updated: 2015-08-06

Locations

1 site across 1 country: China