UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060952 |
|---|---|
| Receipt number | R000069550 |
| Scientific Title | Radiographic Evaluation as a Proxy for Endoscopic Assessment of Post-ESD Clip Closure after Gastric ESD: Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/16 18:54:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Radiographic Evaluation as a Proxy for Endoscopic Assessment of Post-ESD Clip Closure after Gastric ESD: Prospective Observational Study
Acronym
REPLACE-G Study
Scientific Title
Radiographic Evaluation as a Proxy for Endoscopic Assessment of Post-ESD Clip Closure after Gastric ESD: Prospective Observational Study
Scientific Title:Acronym
REPLACE-G Study
Region
| Japan |
Condition
Condition
Early gastric cancer and gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the reliability of radiographic assessment of closure maintenance after clip closure following gastric ESD, the number of clips will be confirmed on both follow-up radiographic examination and endoscopic evaluation, and the findings will be compared.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate of the number of clips between radiographic examination and endoscopic evaluation on postoperative Day 1 following clip closure after endoscopic submucosal dissection for early gastric cancer and gastric adenoma.
Key secondary outcomes
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
Abdominal X-ray examination
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with lesions suspected to be early gastric cancer or gastric adenoma based on endoscopic diagnosis.
2. Lesions in which the post-resection mucosal defect does not extend to the esophagus or the duodenum.
3. Lesions measuring less than 50 mm in diameter.
Key exclusion criteria
1. A history of endoscopic treatment for upper gastrointestinal lesions within 28 days prior to enrollment.
2. Planned concomitant endoscopic treatment for esophageal or duodenal lesions.
3. Women who are pregnant, may be pregnant, or are breastfeeding.
4. Patients with psychiatric disorders that preclude adequate understanding of the study.
5. Patients with a history of gastric surgical resection.
6. Patients who have undergone gastric tube reconstruction.
7. Patients deemed unsuitable for participation in this study by the attending physician or the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Chiba |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1 Chuo, Ota-ku, Tokyo, Japan
TEL
03-3775-3111
h.chiba04@gmail.com
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Chiba |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1 Chuo, Ota-ku, Tokyo, Japan
TEL
03-3775-3111
Homepage URL
h.chiba04@gmail.com
Sponsor or person
Institute
Omori Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omori Red Cross Hospital
Address
4-30-1 Chuo, Ota-ku, Tokyo, Japan
Tel
03-3775-3111
h.chiba04@gmail.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 | 03 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After performing ESD in eligible patients, mucosal defect closure will be achieved using endoscopic clips. Radiographic examination will be conducted on the day of the procedure (Day 0), and both radiographic and endoscopic examinations will be performed on postoperative Day 1. The number of clips will be confirmed at each assessment to validate the reliability of radiographic evaluation for determining maintenance of closure.
The observation period will extend from the day of ESD (Day 0) to 30 days postoperatively. The primary endpoint will be assessed on Day 1, and adverse events will be monitored through Day 30.
Management information
Registered date
| 2026 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069550
