Early Gastric CancerNCT04411589
The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System
A study testing magnifying endoscopy with optical enhancement system and white light endoscopy system in people with Early Gastric Cancer, run by Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- magnifying endoscopy with optical enhancement system and white light endoscopy system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- A history of gastrectomy
- Active gastrointestinal bleeding or advanced gastric carcinoma
- Coagulopathy or severe underlying diseases
- Pregnancy or lactation
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PHD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Early Gastric Cancer
- Being tested
- magnifying endoscopy with optical enhancement system, white light endoscopy system
- Keywords
- Early gastric cancer, Optical enhancement system
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnifying endoscopy with optical enhancement systemDevice
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 systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnifying endoscopy with optical enhancement system group | Experimental | Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system. Receives: Device: magnifying endoscopy with optical enhancement system |
| white light endoscopy group | Active comparator | Patients in this group go through gastroscopy under white light endoscopy. Receives: Device: white light endoscopy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
sensitivity, specificity of diagnostic performances of GIN and EGC
Measured: 3 months
positive predictive value of diagnostic performances of GIN and EGC
Measured: 3 months
negative predictive value of diagnostic performances of GIN and EGC
Measured: 3 months
diagnostic accuracy in a per-biopsy analysis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 May 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD, PhD, Principal investigator, Shandong University Qilu hosipital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411589
- Sponsor's protocol ID
- 2018SDU-QILU-125
- Status last verified
- Sep 2020
- First submitted
- 24 May 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wan M, Li GC, Ma MJ, Liu J, Li Z, Zuo XL, Li YQ. Optical enhancement with magnification versus white-light endoscopy for detecting gastric intestinal metaplasia and neoplasia: a randomized controlled trial. Gastrointest Endosc. 2025 Sep;102(3):337-344.e1. doi: 10.1016/j.gie.2025.02.015. Epub 2025 Feb 15.
PubMed 39956464
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04411589
- Acronym / sponsor ID
- 2018SDU-QILU-125
- Conditions
- Early Gastric Cancer
- Keywords
- Early gastric cancer, Optical enhancement system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnifying endoscopy with optical enhancement system group | Experimental | Device: magnifying endoscopy with optical enhancement systemPatients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system. |
| white light endoscopy group | Active comparator | Device: white light endoscopy systemPatients in this group go through gastroscopy under white light endoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- A history of gastrectomy
- Active gastrointestinal bleeding or advanced gastric carcinoma
- Coagulopathy or severe underlying diseases
- Pregnancy or lactation
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnifying endoscopy with optical enhancement systemA 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. | Device | Magnifying endoscopy with optical enhancement system group |
| white light endoscopy systemA 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. | Device | white light endoscopy group |
Primary outcome
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.
4 secondary outcomes
sensitivity, specificity of diagnostic performances of GIN and EGC
Time frame: 3 months
positive predictive value of diagnostic performances of GIN and EGC
Time frame: 3 months
negative predictive value of diagnostic performances of GIN and EGC
Time frame: 3 months
diagnostic accuracy in a per-biopsy analysis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 39956464Wan M, Li GC, Ma MJ, Liu J, Li Z, Zuo XL, Li YQ. Optical enhancement with magnification versus white-light endoscopy for detecting gastric intestinal metaplasia and neoplasia: a randomized controlled trial. Gastrointest Endosc. 2025 Sep;102(3):337-344.e1. doi: 10.1016/j.gie.2025.02.015. Epub 2025 Feb 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, MD, PhD principal investigator
Shandong University Qilu hosipital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnifying endoscopy with optical enhancement system and white light endoscopy system in people with Early Gastric Cancer, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, MD, PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate of GIN and EGC (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.