Performance test of a diagnostic support program for evaluating the depth of invasion of early gastric cancer

JRCT ID: jRCT1060220108

Registered date:07/03/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: early gastric cancer
• Date of first enrollment: 01/01/2023
• Target sample size: 204
• Study type: Observational

Outcome(s)

• Primary Outcome: Sensitivity of mucosal gastric cancer (M cancer) diagnosed by this program.

Secondary Outcome

1) Specificity of mucosal gastric cancer (M cancer) diagnosed by this program.
2) Diagnostic accuracy rate of mucosal gastric cancer (M cancer) diagnosed by this program.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Individuals who are 20 years of age or older at the time of endoscopic image acquisition.
2. Individuals who can provide early gastric cancer tissue suitable for pathological diagnosis by a pathological evaluator.
3. Individuals who can provide images that meet the following criteria for endoscopic images:
Images captured using White Light mode
Vertical resolution of 700 pixels or more and horizontal resolution of 800 pixels or more (image area)
Images captured using an Olympus or Fujifilm endoscope
Five or more images per lesion
Suitable for deep depth diagnosis, as shown below
The entire gastric tumor is generally visible (without using close-up or magnifying endoscopy, etc.)
The details of the tumor's shape can be observed (without moving the lens too far from the tumor)
Sufficient insufflation is performed.

Exclude criteria

1. The following images are excluded
Images that do not show the gastric tumor (such as normal areas)
Images taken after treatment such as biopsy or clipping, or images with severe bleeding
Images that show foreign objects such as food residue
Blurred or unclear images due to poor focus or other factors
Images that only show a portion of the lesion due to magnifying endoscopy or close-up photography
2. Individuals who have undergone gastric resection or gastric tube reconstruction at the time of endoscopic image acquisition or specimen collection.
3. Individuals with lesions extending to the esophagus or duodenum at the time of endoscopic image acquisition or specimen collection.
4. Individuals with a history of chemotherapy or radiation therapy to the upper abdomen within the year prior to the target endoscopic examination.
5. Patients who have refused to participate in the study.

Related Information

• Primary Sponsor: Kawahara Yoshiro
• Secondary Sponsor: Ryobi Systems co., ltd.