The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System

Shandong University

Status: Unknown

Conditions: Early Gastric Cancer

Treatments: Device: white light endoscopy system; Device: magnifying endoscopy with optical enhancement system

Study type: Interventional

Funder types: Other

Identifiers

NCT04411589

2018SDU-QILU-125

Details and patient eligibility

About

The purpose of this study is to valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.

Full description

Stomach cancer is the second most common cause of cancer death. Endoscopic identification and treatment of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) is essential to improve patients' 5-year survival rates. Conventional endoscopy with white light imaging (WLI) is widely used for endoscopic evaluation of EGCs. However, conventional endoscopic visualization of EGCs has a high rate of interobserver variability and correlates poorly with the histological findings. For this reason, diagnosis has been based mostly on repeated endoscopy with multiple biopsy samples. It has been reported that optical enhancement (OE) system is useful for discriminating cancerous lesions from non-cancerous lesions. The OE system is the newly developed image-enhanced endoscopic technology, which combines high definition white light endoscopy (WLE) and optical filters that limit the spectral characteristics of the illumination light. The optical filters can achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum creating a continuous wavelength spectrum. Magnifying endoscopy is useful for observing the mucosal structures and microvessels. The VS theory proposed by Yao K is widely used in Magnifying endoscopy with optical enhancement system (ME-OE). Based on technical considerations, it is conceivable that ME-OE imaging techniques might have a distinct advantage over WLE in the diagnosis of endoscopic lesions. However, few reports have objectively proved that ME-OE is superior to WLE in the detection rate and diagnostic efficiency of EGCs.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-80 years with H. pylori infection or histologically verified gastric lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC)
• Or patients aged 40-80 years from a region with high incidence of gastric cancer
• Or patients aged 40-80 years with first-degree relative of patients with gastric cancer
• Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or pickle diet or smoking or heavy drinking)

Exclusion criteria

• A history of gastrectomy
• Active gastrointestinal bleeding or advanced gastric carcinoma
• Coagulopathy or severe underlying diseases
• Pregnancy or lactation
• Absence of informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Magnifying endoscopy with optical enhancement system group

Experimental group

Description:

Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.

Treatment:

Device: magnifying endoscopy with optical enhancement system

white light endoscopy group

Active Comparator group

Description:

Patients in this group go through gastroscopy under white light endoscopy.

Treatment:

Device: white light endoscopy system