Different Endoscopic Gastric Cancer Risk Assessments

Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer

The Kimura-Takamoto classification established in Japan can observe the extent of gastric atrophy in real-time under endoscopy, and diffuse atrophy also indicates an increased risk of gastric cancer. Recent studies have found that the evaluation of intestinal metaplasia score (EGGIM score) of various stomach parts by electronic staining can well identify OLGIM III\ IV patients. Although the Kimura-Takamoto classification and EGGIM score can evaluate the risk of gastric cancer in patients, only in cross-sectional studies, it is not clear the diagnostic value of risk assessment in population screening. Early gastric cancer has the characteristics of hidden lesions and a high rate of clinical missed diagnosis. Concentrating high-risk groups through risk scores is expected to guide endoscopic doctors to conduct a targeted careful examination. However, it is not clear whether Kimura-Takamoto classification and EGGIM score can improve the detection rate of early gastric cancer in clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer Screening
• Intervention / Treatment: Procedure: Kimura-Takemoto classification; Procedure: EGGIM

• Study Type: Interventional
• Enrollment (Anticipated): 3500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan-qing Li; Phone Number: +8653188369277; Email: liyanqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250001
      • Recruiting
      • Qilu Hospital, Shandong University
      • Contact: Yanqing Li, PhD,MD; Phone Number: 053182169385; Email: liyanqing@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 40-80 years undergoing gastroscopy
• Patients intend to undergo ESD treatment

Exclusion Criteria:

• patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
• Patients with previous surgical procedures on the stomach
• patients with contraindications to biopsy
• Patients who refuse to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kimura-Takemoto classification	Procedure: Kimura-Takemoto classification; All patients were given two risk scores, the order of which was randomly determined.
Active Comparator: EGGIM	Procedure: EGGIM; All patients were given two risk scores, the order of which was randomly determined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early gastric cancer detection rate	The detection rate of early gastric cancer	36 months

Collaborators and Investigators

• Sponsor: Yanqing Li

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): July 4, 2025

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2022-SDU-QILU-120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No