Clinical trial NCT02516735: I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia
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 Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Intestinal Metaplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 164
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: seven months
measure: 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
timeFrame: seven months
Secondary outcomes:
measure: Number of biopsies needed in per group
timeFrame: seven months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References: