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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02725034
Other study ID # 2016SDU-QILU-02
Secondary ID
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. completion date
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


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
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