Exploratory clinical trial to evaluate the usefulness of Amber-red Color Imaging (ACI) for visualization of submucosal vessels during endoscopic submucosal dissection

An exploratory randomized controlled trial to evaluate the usefulness of Amber-red Color Imaging for visualization of submucosal vessels during endoscopic submucosal dissection - An exploratory randomized controlled trial to evaluate the usefulness of Amber-red Color Imaging for visualization of submucosal vessels during endoscopic submucosal dissection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060876

Enrollment

Registered

2026-04-01

Start date

2026-03-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

early esophageal cancer, early gastric cancer, early rectal cancer

Interventions

Intervention 1 (ACI group): All procedures during ESD, including mucosal incision, submucosal dissection, and hemostatic treatment, are performed using Amber-red Color Imaging (ACI) Intervention 2 (W

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number of bleeding events during endoscopic submucosal dissection	—

Secondary

Measure	Time frame
Secondary endpoints included the number of prophylactic hemostatic procedures, hemostasis time, endoscopist-reported psychological stress during hemostasis, submucosal dissection speed, total procedure time, and the incidence of intraoperative perforation.	—

Countries

Japan

Contacts

Public ContactRyo Shimizu

Toho University Omori Medical Center Division of Gastroenterology and Hepatology

ryou.shimizu@med.toho-u.ac.jp0337624151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026