Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement

Gastric Intestinal Metaplasia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02725034
• Other study ID #: 2016SDU-QILU-02
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2016
• Last updated: March 30, 2016
• Start date: January 2016

Study information

• Verified date: March 2016
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 18678827666
• Email: qiluliyanqing[@]gmail.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commision of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement 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. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement 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: 160
• Est. primary completion date: August 2016
• 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:
• Standard endoscopy

• High definition endoscopy with Optic Enhancement

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 high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis		eight months	No
Primary	Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis		eight months	No
Secondary	Number of biopsies needed in per group		eight months	No