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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
164
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
RECRUITINGDifference 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
Number of biopsies needed in per group
Time frame: seven months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.