Efficacy of Artificial Intelligence-Assisted Endoscopy for the Detection of Synchronous Lesions during Endoscopic Submucosal Dissection: A Multicenter Randomized Trial

Efficacy of Artificial Intelligence-Assisted Endoscopy for Detecting Synchronous Lesions During Endoscopic Submucosal Dissection of Gastric Tumors: A Prospective Multicenter Randomized Controlled Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011061

Enrollment

416

Registered

2025-09-23

Start date

2025-10-27

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : [1] Intervention Arm Artificial Intelligence-Assisted High-Definition Endoscopy (AI-HDE) Timing and frequency/duration: Applied once (on the day of ESD, during the pre-scan phase)

observation time = 1 minute Protocol: Confirm the location of the index lesion for ESD using standard white-light endoscopy. Perform a complete inspection of the entire stomach with high-definition en

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Adults older than 19 years and younger than 80 years. (2) Patients diagnosed with gastric adenoma or early gastric cancer who are scheduled to undergo, or are undergoing, endoscopic submucosal dissection (ESD). (3) Patients whose diagnostic endoscopy for the gastric lesion was not performed by the same endoscopist who will perform the ESD. (4) Patients who have received an explanation of the study and have provided written informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients with severe systemic disease or coagulation disorders. (2) Patients with a history of prior endoscopic treatment for gastric tumors. (3) Pregnant or breastfeeding women. (4) Patients with a history of gastrectomy. (5) Patients with unstable vital signs making upper endoscopy unsafe. (6) Patients who refuse to provide written informed consent. (7) Any other cases in which the investigator judges participation in the clinical trial to be inappropriate.

Design outcomes

Primary

Measure	Time frame
Detection rate of synchronous lesions during endoscopic submucosal dissection	—

Secondary

Measure	Time frame
Number of biopsies performed during endoscopic submucosal dissection;Observation time before endoscopic submucosal dissection;Characteristics of detected synchronous lesions;Characteristics of synchronous and metachronous lesions detected in patients undergoing follow-up endoscopy	—

Countries

Korea, Republic of

Contacts

Public ContactSu Young Kim

Yonsei University, Wonju Severance Christian Hospital

breeze1212@naver.com+82-33-741-1229

Outcome results