The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System
Primary Purpose
Early Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
magnifying endoscopy with optical enhancement system
white light endoscopy system
Sponsored by
About this trial
This is an interventional diagnostic trial for Early Gastric Cancer focused on measuring Early gastric cancer, Optical enhancement system
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
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Magnifying endoscopy with optical enhancement system group
white light endoscopy group
Arm Description
Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.
Patients in this group go through gastroscopy under white light endoscopy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
sensitivity, specificity of diagnostic performances of GIN and EGC
positive predictive value of diagnostic performances of GIN and EGC
negative predictive value of diagnostic performances of GIN and EGC
diagnostic accuracy in a per-biopsy analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04411589
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
Early gastric cancer, Optical enhancement system
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnifying endoscopy with optical enhancement system group
Arm Type
Experimental
Arm Description
Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system.
Arm Title
white light endoscopy group
Arm Type
Active Comparator
Arm Description
Patients in this group go through gastroscopy under white light endoscopy.
Intervention Type
Device
Intervention Name(s)
magnifying endoscopy with optical enhancement system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
white light endoscopy system
Intervention Description
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.
Primary Outcome Measure Information:
Title
detection rate of GIN and EGC
Description
The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
sensitivity, specificity of diagnostic performances of GIN and EGC
Time Frame
3 months
Title
positive predictive value of diagnostic performances of GIN and EGC
Time Frame
3 months
Title
negative predictive value of diagnostic performances of GIN and EGC
Time Frame
3 months
Title
diagnostic accuracy in a per-biopsy analysis
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, MD, PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Organizational Affiliation
Shandong University Qilu hosipital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PHD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System
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