The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System
- Conditions
- Early Gastric Cancer
- Interventions
- Device: white light endoscopy systemDevice: magnifying endoscopy with optical enhancement system
- Registration Number
- NCT04411589
- Lead Sponsor
- Shandong University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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)
- A history of gastrectomy
- Active gastrointestinal bleeding or advanced gastric carcinoma
- Coagulopathy or severe underlying diseases
- Pregnancy or lactation
- Absence of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description white light endoscopy group white light endoscopy system Patients in this group go through gastroscopy under white light endoscopy. Magnifying endoscopy with optical enhancement system group magnifying endoscopy with optical enhancement system Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.
- Primary Outcome Measures
Name Time Method detection rate of GIN and EGC 3 months The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.
- Secondary Outcome Measures
Name Time Method sensitivity, specificity of diagnostic performances of GIN and EGC 3 months positive predictive value of diagnostic performances of GIN and EGC 3 months negative predictive value of diagnostic performances of GIN and EGC 3 months diagnostic accuracy in a per-biopsy analysis 3 months
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China