UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060876 |
|---|---|
| Receipt number | R000068494 |
| Scientific Title | An exploratory randomized controlled trial to evaluate the usefulness of Amber-red Color Imaging for visualization of submucosal vessels during endoscopic submucosal dissection |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/09 18:19:28 |
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Basic information
Public title
Exploratory clinical trial to evaluate the usefulness of Amber-red Color Imaging (ACI) for visualization of submucosal vessels during endoscopic submucosal dissection
Acronym
ACI-ESD study
Scientific Title
An exploratory randomized controlled trial to evaluate the usefulness of Amber-red Color Imaging for visualization of submucosal vessels during endoscopic submucosal dissection
Scientific Title:Acronym
An exploratory randomized controlled trial to evaluate the usefulness of Amber-red Color Imaging for visualization of submucosal vessels during endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early esophageal cancer, early gastric cancer, early rectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of bleeding events during endoscopic submucosal dissection
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | 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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Fujimoto |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL
0337624151
ai.fujimoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Shimizu |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
ryou.shimizu@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center, Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Ryo Shimizu
Funding Source
Organization
Fujifilm Corporation (provision of endoscopic equipment)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo
Tel
0337624151
ai.fujimoto@med.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068494
