Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060876) titled 'Exploratory clinical trial to evaluate the usefulness of Amber-red Color Imaging (ACI) for visualization of submucosal vessels during endoscopic submucosal dissection' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Toho University Omori Medical Center, Division of Gastroenterology and Hepatology

Condition: Condition - early esophageal cancer, early gastric cancer, early rectal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate whether the use of Amber-red Color Imaging (ACI) during endoscopic submucosal dissection reduces the number of intraoperative bleeding events through improved visualization of submucosal vessels. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention 1 (ACI group): All procedures during ESD, including mucosal incision, submucosal dissection, and hemostatic treatment, are performed using Amber-red Color Imaging (ACI) Interventions/Control_2 - Intervention 2 (WLI group): During endoscopic submucosal dissection (ESD), all procedures including mucosal incision, submucosal dissection, and hemostatic treatment in the event of bleeding are performed using white-light imaging (WLI) mode.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1 Patients with suspected early esophageal, gastric, or rectal cancer diagnosed as eligible for ESD 2 No prior surgery, radiotherapy, or chemotherapy for the target organ 3 Not residual or recurrent lesions after endoscopic treatment 4 Age 20-90 years at the time of consent 5 ECOG performance status 0 or 1 6 Laboratory values within 90 days before enrollment: hemoglobin >= 8.0 g/dL and platelet count >= 100000 7 Written informed consent obtained Key exclusion criteria - 1. Patients scheduled for ESD of multiple lesions 2. Patients with bleeding tendency (e.g., liver cirrhosis, hematologic disorders) 3. Patients receiving antithrombotic therapy who cannot appropriately discontinue or continue treatment according to guidelines 4. Patients on hemodialysis 5. Patients with residual or recurrent lesions after previous endoscopic treatment Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 03 Month 16 Day Anticipated trial start date - 2026 Year 03 Month 10 Day Last follow-up date - 2029 Year 03 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068494

Disclaimer: Curated by HT Syndication.