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

September 23, 2020 updated by: Yanqing Li, Shandong University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Magnifying endoscopy with optical enhancement system group
Patients in this group go through gastroscopy under the 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.
ACTIVE_COMPARATOR: white light endoscopy group
Patients in this group go through gastroscopy under white light endoscopy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection rate of GIN and EGC
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Time Frame
sensitivity, specificity of diagnostic performances of GIN and EGC
Time Frame: 3 months
3 months
positive predictive value of diagnostic performances of GIN and EGC
Time Frame: 3 months
3 months
negative predictive value of diagnostic performances of GIN and EGC
Time Frame: 3 months
3 months
diagnostic accuracy in a per-biopsy analysis
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yanqing Li, MD, PhD, Shandong University Qilu hosipital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (ACTUAL)

June 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on magnifying endoscopy with optical enhancement system

3
Subscribe