Clinical trial NCT04411589: The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System
Official title: Evaluation of the Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System in Early Gastric Cancer and Intraepithelial Neoplasia: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Gastric Cancer
Keywords: Early gastric cancer, Optical enhancement system
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
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 valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: detection rate of GIN and EGC
timeFrame: 3 months
Secondary outcomes:
measure: sensitivity, specificity of diagnostic performances of GIN and EGC
timeFrame: 3 months
measure: positive predictive value of diagnostic performances of GIN and EGC
timeFrame: 3 months
measure: negative predictive value of diagnostic performances of GIN and EGC
timeFrame: 3 months
measure: diagnostic accuracy in a per-biopsy analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Shandong University Qilu hosipital, China
name: Yanqing Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: