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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Random

Brief 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 Summary: 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.
Sponsor: Shandong University

Current Primary Outcome:

  • Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-pateint analysis [ Time Frame: seven months ]
  • Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis [ Time Frame: seven months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of biopsies needed in per group [ Time Frame: seven months ]

Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: July 30, 2015
Date Started: May 2015
Date Completion:
Last Updated: August 3, 2015
Last Verified: August 2015