Clinical Trial: A Prospective Non-Inferiority Trial Comparing AI-Assisted Conventional Endoscopy with Expert Magnifying Endoscopy for the Detection of Esophageal and Gastric Neoplasms (Japan)

Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060929) titled 'A Prospective Study on the Utility of an Artificial Intelligence-Based Detection System for Esophageal and Gastric Tumors' on March 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - The Jikei University School of Medicine

Condition: Condition - Esophageal Cancer, Gastric Cancer, Gastric adenoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to demonstrate the non-inferiority of the sensitivity for detecting early esophageal and gastric cancers by screening endoscopists using conventional endoscopy with AI assistance compared with expert endoscopists using magnifying endoscopy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Patients with confirmed esophageal or gastric cancer will undergo endoscopic examination using a conventional esophagogastroduodenoscopy (EG-860R) combined with an AI-based image diagnostic support system (CADEYE). The examination will be performed by screening endoscopists who have passed the Jikei University certification examination, are qualified to independently perform esophagogastroduodenoscopy, and have experience with fewer than 100 endoscopic treatments for esophageal and gastric cancers.Subsequently, with the AI system (CADEYE) turned off, an expert endoscopist will perform the examination using a magnifying endoscope (EG-860Z). Expert endoscopists are defined as physicians who have performed 100 or more endoscopic treatments for esophageal and gastric cancers and independently conduct endoscopic therapy.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with a current diagnosis of esophageal cancer or gastric cancer (including adenoma) who are scheduled to undergo diagnostic esophagogastroduodenoscopy at Jikei University Kashiwa Hospital or Jikei University Katsushika Medical Center. Patients who have received a full explanation of the study, have demonstrated sufficient understanding, and have provided written informed consent of their own free will to participate in the study. Key exclusion criteria - Patients who are minors (under 20 years of age). Patients who have received chemotherapy for a malignant tumor within the past 12 months. Patients in whom biopsy cannot be performed at the time of endoscopy (e.g., due to ongoing antithrombotic therapy). Patients in whom iodine staining of the esophagus cannot be performed due to allergy or other contraindications. Patients who are deemed inappropriate for enrollment in this study by the treating physician or examining endoscopist for any other reason. Target Size - 138

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 15 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069727

Disclaimer: Curated by HT Syndication.