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

Gastric Intestinal Metaplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02516735
• Other study ID #: 2015SDU-QILU-G07
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2015
• Last updated: August 3, 2015
• Start date: May 2015

Study information

• Verified date: August 2015
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 18678827666
• Email: qiluliyanqing[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia

Intervention

Device:
• I-scan with magnification

• Standard endoscopy

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		seven months	No
Primary	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		seven months	No
Secondary	Number of biopsies needed in per group		seven months	No