Efficacy of CADe System in Detecting Gastric Neoplasia

February 5, 2026 updated by: Hon Chi Yip, Chinese University of Hong Kong

Efficacy of Computer Aided Detection (CADe) System in Detecting Gastric Neoplasia - a Prospective Tandem Study

Gastric cancer remains the 5th most common cancers worldwide. It also ranked 5th in the cancer related mortality, causing more than 650'000 deaths per year. Survival of gastric cancer is directly related to the stage of the presentation, with early stage cancers having a significantly better survival. Patients with stage I gastric cancer generally have a 5-year survival of more than 90%. In particular, T1a cancer confined to the mucosa are amenable for endoscopic resection, and patients who underwent such treatment have an excellent survival of 97.2% at 5 years. These patients are not only able to survive longer but also with good quality of life through organ preservation.

However, diagnosis of gastric cancer at an early stage has always been difficult. A meta-analysis of 22 studies from both East and Western population showed a gastric cancer miss rate of 9.4%. Early gastric cancer usually presents with subtle mucosal changes that are hard to detect endoscopically, especially for endoscopists with limited experience in early cancer diagnosis. Background chronic inflammation and high frequency of non-neoplastic lesions often pose significant diagnostic challenges for endoscopists to detect real neoplastic changes. In high incidence countries such as Japan and Korea, the combination of national screening programme as well as good endoscopy training program facilitated high proportion of early gastric cancer detection. Previous studies have showed that significant survival outcome difference between countries with high versus low early cancer detection rate.

Artificial intelligence has emerged as one of the promising technologies that helps enhance endoscopic performance. Numerous high quality randomized studies have demonstrated that computer assisted detection (CADe) system significantly improved colonic adenoma detection rate during screening colonoscopy. Development of gastric cancer CADe system has been much slower than colonic polyp detection. Despite the publication of numerous retrospective studies utilizing endoscopic images in differentiating benign versus malignant gastric lesions, there were only very few completed systems available for clinical real time application. A single centre randomized controlled trial from China demonstrated an improvement in the gastric neoplasm miss rate from 27.3% to 6.1 % when utilizing a novel CADe system.

A novel CADe prototype system (OIP-Ge1, Olympus Medical Corporations, Tokyo, Japan) has recently been developed. The system was developed through collaboration of multiple experts in diagnosing early gastric cancer, collecting more than 100'000 endoscopic images from dozens of high volume centres in Japan. There is currently no prospective clinical data on the actual performance of the prototype CADe system, especially when applied in regions with low proportion of early gastric cancer detection.

The purpose of this study is to investigate the clinical utility of the new CADe system in detection of gastric neoplasia among high risk patients.

If the current study confirms the significant difference in miss rate of gastric neoplasia with the CADe system, a multicentred international randomized controlled trial is planned to compare the efficacy of gastric neoplasia detection with or without the system.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >=18

  • Deemed at high risk of gastric cancer, defined as below:

    1. Family history of stomach cancer (1st degree relative) for screening, or
    2. Known gastric atrophy/ intestinal metaplasia requiring surveillance, or
    3. Suspicious lesion for repeat diagnostic OGD, or
    4. History of gastric dysplasia / early gastric cancer with endoscopic resection for surveillance
    5. Newly diagnosed early gastric cancer, workup for synchronous cancers

Exclusion Criteria:

  • History of gastrectomy (For any reason, including benign and malignant disease)
  • Patient who refused to participate
  • Patients deemed not fit for consent, including minor patients
  • Pregnancy
  • Other cases deemed by the examining physician as unsuitable for safe treatment

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CADe System Group
During the procedure, the stomach would be examined with the assistance of CADe system by endoscopist.
Device: CADe System
The endoscopy would be performed using standardized video processing system (EVIS-X1 CV-1500, Olympus Medical Corporations, Tokyo, Japan) and gastroscope (GIF-EZ1500, GIF-XZ1200). A soft black hood (MAJ-1989) would be attached to the distal end of the endoscope. The video processing system would be connected to the OIP-Ge1 (Olympus Medical Corporations, Tokyo, Japan), the novel CADe system, allowing simultaneous artificial intelligence assisted lesion detection, when turned on using conventional white light imaging (WLI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with missed gastric neoplasia during first endoscopy without CADe system
Time Frame: 1 day
Number of patients in whom at least one histologically confirmed gastric neoplasia (Vienna III-V) is not identified during the first endoscopy without CADe, but is identified during the second endoscopy with CADe, divided by the total number of patients undergoing both examinations (unit: %) Miss rate (%) = [Number of patients with ≥1 neoplasia detected only on 2nd endoscopy with CADe] ÷ [Total number of patients undergoing both 1st and 2nd endoscopies] × 100.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric neoplasia detection rate during second endoscopy with CADe System
Time Frame: 1 day
Suspicious lesion(s) detected would appear as a green box on the main video monitor. Consistent appearance of the green box for more than 2 seconds on the same target area would be considered as a positively detected lesion by the CADe system. Gastric neoplasia detection rate is defined as the gastric neoplasia detection rate during the 2nd endoscopy examination with the assistance of CADe system. (unit: %) Detection rate (%) = [Number of patients with ≥1 neoplasia detected on 2nd endoscopy with CADe] ÷ [Total number of patients undergoing 2nd endoscopy with CADe] × 100.
1 day
Time to detect each gastric neoplasia with CADe System
Time Frame: 1 day
Time in seconds from green box to appear to the stable dentification of a histologically confirmed neoplastic lesion (Vienna III-V), recorded automatically by the CADe system or by time-stamped video review. (unit: second)
1 day
Detection rate of non-neoplastic gastric lesions with CADe System
Time Frame: 1 day

Number of patients in whom at least one endoscopically identified non-neoplastic lesion is detected during the CADe-assisted examination divided by total number of patients undergoing CADe-assisted examination (unit: %).

Detection rate (%) = [Number of patients with ≥1 non-neoplastic gastric lesion detected] ÷ [Total number of patients examined] × 100.
1 day
Miss rate of gastric neoplasia detection with CADe System
Time Frame: 1 day

Number of patients in whom at least one histologically confirmed gastric neoplasia is visible on the recorded video of the second endoscopy (on retrospective expert review) but is not detected by CADe (no stable box ≥2 seconds), divided by the total number of patients with gastric neoplasia on that second examination (unit: %).

Miss rate (%) = [Number of patients with ≥1 neoplastic lesion visible on video but not detected by CADe] ÷ [Total number of patients with gastric neoplasia during 2nd endoscopy] × 100.
1 day
Total procedure time for screening endoscopy
Time Frame: 1 day
Time in minutes from scope insertion to scope withdrawal, including the first examination without CADe and the second examination with CADe, measured using the endoscopy unit's time stamps. (unit: minute)
1 day
Mean number of lesions detected per endoscopy (neoplastic and non-neoplastic)
Time Frame: 1 day

Total count of lesions (neoplastic and non-neoplastic) detected during each examination (first without CADe, second with CADe), divided by the number of procedures, reported as mean ± SD per procedure.

Mean lesions per procedure = [Total number of lesions detected in all procedures] ÷ [Total number of procedures].
1 day
Video recording
Time Frame: 1 day
Digital high-definition video capture system integrated with the endoscopy tower, summarized as percentage of procedures with complete, analyzable recordings. (unit: yes/no, %) Proportion with complete recording (%) = [Number of procedures with complete video adequate for review] ÷ [Total number of procedures] × 100.
1 day

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRE-2025.465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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