- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411589
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
Status
Unknown
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018SDU-QILU-125
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.
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