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

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411589
• Other study ID #: 2018SDU-QILU-125
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2020
• Source: Shandong University
• Contact: Yanqing Li, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• magnifying endoscopy with optical enhancement system
A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. After visualization in white light mode, the stomach was reinspected by using OE mode2. Then, in vivo diagnoses of lesions were made by using OE mode1 according to VS theory. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.
• white light endoscopy system
A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.

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	detection rate of GIN and EGC	The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.	3 months
Secondary	sensitivity, specificity of diagnostic performances of GIN and EGC		3 months
Secondary	positive predictive value of diagnostic performances of GIN and EGC		3 months
Secondary	negative predictive value of diagnostic performances of GIN and EGC		3 months
Secondary	diagnostic accuracy in a per-biopsy analysis		3 months