UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061989 |
|---|---|
| Receipt number | R000070815 |
| Scientific Title | A study on the efficacy of Endoscopic Submucosal Dissection (ESD) under the use of a 3D endoscope system |
| Date of disclosure of the study information | 2026/06/20 |
| Last modified on | 2026/06/20 20:30:34 |
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Basic information
Public title
Study on the effectiveness of Endoscopic Submucosal Dissection (ESD) using a 3D endoscopy system
Acronym
3D-ESD Study
Scientific Title
A study on the efficacy of Endoscopic Submucosal Dissection (ESD) under the use of a 3D endoscope system
Scientific Title:Acronym
3D-ESD Efficacy Study
Region
| Japan |
Condition
Condition
Esophageal tumor, Gastric tumor, Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the therapeutic outcomes and clinical characteristics of endoscopic submucosal dissection (ESD) using a 3D endoscopy system for esophageal, gastric, and colorectal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Procedure completion rate: The rate of completing ESD using only the 3D endoscopy system from local injection to lesion resection (Assessed during the procedure)
Key secondary outcomes
Resection time: Time from the start of local injection to the end of lesion resection (Assessed during the procedure)
Dissection speed: Resected specimen diameter divided by resection time (Assessed during the procedure)
Endoscopic en bloc resection rate (Assessed during the procedure)
Pathological en bloc resection rate (Assessed at the time of pathological evaluation)
Intraoperative perforation rate: Confirmed by free gas on X-ray/CT or endoscopically during the procedure (Assessed during the procedure)
Postoperative complications: Incidence of bleeding, delayed perforation, etc. (Assessed from immediately after ESD up to 14 days postoperatively)
Operator feedback for evaluating fatigue and other factors using Visual Analogue Scale (VAS) (Assessed immediately after the procedure)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic submucosal dissection (ESD) using a 3D endoscopy system
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are eligible for enrollment:
1. Patients with lesions suspected to be superficial esophageal cancer, early gastric cancer, early colorectal cancer, esophageal dysplasia, gastric adenoma, or colorectal adenoma based on endoscopic diagnosis.
2. Aged 20 years or older at the time of registration.
3. ECOG Performance Status (PS) of 0 or 1.
4. Lesion size of 50 mm or less.
5. The most recent blood test within 30 days prior to registration meets all of the following conditions (no blood transfusions within 14 days prior to the blood test used for registration):
- Hemoglobin >= 9 g/dL
- Platelet count >= 100,000/mm3
- AST, ALT <= 100
- Serum creatinine <= 2.0 mg/dL
6. Capable of being followed up for 14 days after treatment.
7. Written informed consent has been obtained for participation in the trial.
Key exclusion criteria
1. History of endoscopic treatment for upper or lower gastrointestinal tract lesions within 28 days prior to registration.
2. Scheduled for endoscopic treatment for the upper or lower gastrointestinal tract within 14 days after treatment.
3. Planned to treat multiple lesions simultaneously.
4. Background of active inflammatory bowel disease (ulcerative colitis, Crohn's disease).
5. History of radiation therapy in the planned ESD area.
6. Women who are potentially pregnant, currently pregnant, or breastfeeding.
7. Patients with psychiatric symptoms who are unable to sufficiently understand this study.
8. History of myocardial infarction or unstable angina within the past 3 months.
9. Patients with blood coagulation disorders (regardless of antithrombotic drug use).
10. Patients with active bacterial or fungal infections (having a fever of 38.5 degrees C or higher and complicated by bacterial infection confirmed by imaging or bacteriological examination).
11. Patients with respiratory diseases requiring continuous oxygen administration.
12. Patients with poorly controlled hypertension.
13. Other cases where the attending physician judges participation in this study to be inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
141-0022
Address
NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | Hoshu |
| Middle name | |
| Last name | Kurebayashi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
141-0022
Address
NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6111
Homepage URL
kinsmen-topped4l@icloud.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Hoshu Kurebayashi
Funding Source
Organization
NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NTT Medical Center Tokyo
Address
NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawa-ku, Tokyo
Tel
03-3448-6111
kinsmen-topped4l@icloud.com
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 | 06 | Month | 20 | 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 | 10 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 06 | Month | 20 | Day |
Last modified on
| 2026 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070815
