UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058176 |
|---|---|
| Receipt number | R000066504 |
| Scientific Title | Improved Diagnostic Accuracy and Safety of Gel-Based EUS for Deep Submucosal Invasion in Early Gastric Cancer |
| Date of disclosure of the study information | 2025/06/14 |
| Last modified on | 2026/07/27 17:16:27 |
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Basic information
Public title
Improved Diagnostic Accuracy and Safety of Gel-Based EUS for Deep Submucosal Invasion in Early Gastric Cancer
Acronym
Improved Diagnostic Accuracy and Safety of Gel-Based EUS for Deep Submucosal Invasion in Early Gastric Cancer
Scientific Title
Improved Diagnostic Accuracy and Safety of Gel-Based EUS for Deep Submucosal Invasion in Early Gastric Cancer
Scientific Title:Acronym
Improved Diagnostic Accuracy and Safety of Gel-Based EUS for Deep Submucosal Invasion in Early Gastric Cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Accurate diagnosis of the depth of invasion is critical in determining appropriate treatment in early gastric cancer (EGC), especially when submucosal deep invasion (d-SM) is suspected. The diagnostic accuracy of conventional endoscopic ultrasonography (EUS) remains limited, however, and the use of large volumes of de-aerated water carries a risk of aspiration pneumonia.This retrospective study evaluated the diagnostic performance and safety of gel-based EUS, a method that uses a transparent, viscous gel instead of water.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic sensitivity, specificity, and accuracy were compared between the gel-EUS and C-EUS groups.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All examined lesions were suspected of submucosal invasion early gastric cancer on WLI.
Key exclusion criteria
None
Target sample size
79
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Fujimoto |
Organization
Toho University Omori Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
1438541
Address
6-11-1, Omori-nishi, Otaku, Tokyo, Japan
TEL
0337624151
aifujimoto0517@gmail.com
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Fujimoto |
Organization
Toho University Omori Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
1438541
Address
6-11-1, Omori-nishi, Otaku, Tokyo, Japan
TEL
0337624151
Homepage URL
aifujimoto0517@gmail.com
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University School of Medicine Ethics Committee
Address
5-21-16, Omori-nishi, Otaku, Tokyo, Japan
Tel
0337624151
med.rinri@ext.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
| 2025 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Surgical Endoscopy https://doi.org/10.1007/s00464-025-12335-7
Publication of results
Published
Result
URL related to results and publications
Surgical Endoscopy https://doi.org/10.1007/s00464-025-12335-7
Number of participants that the trial has enrolled
79
Results
This retrospective study compared gel-based endoscopic ultrasonography (gel-EUS) with conventional water-based EUS in 81 early gastric cancer lesions. Gel-EUS showed higher sensitivity for diagnosing deep submucosal invasion (83.3% vs. 25.0%), significantly shorter examination time (3 vs. 8 minutes), and fewer aspiration events. These findings suggest that gel-EUS is a safe and useful method for preoperative assessment of invasion depth in early gastric cancer.
Results date posted
| 2026 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 79 patients with 81 early gastric cancer lesions suspected of submucosal invasion were enrolled between October 2017 and December 2024. The gel-EUS group included 27 patients with 29 lesions, and the conventional EUS group included 52 patients with 52 lesions. There were no significant differences between the groups in age, sex, lesion size, tumor location, macroscopic type, or histological type.
Participant flow
A total of 27 patients with 29 lesions were enrolled in the gel-EUS group, and 52 patients with 52 lesions were enrolled in the conventional EUS group. In the conventional EUS group, the examination was discontinued in five patients. Therefore, 27 patients with 29 lesions in the gel-EUS group and 47 patients with 47 lesions in the conventional EUS group were included in the analyses of examination time and diagnostic accuracy. All 79 patients with 81 lesions were included in the analyses of patient and lesion characteristics.
Adverse events
No serious adverse events were observed. Aspiration occurred in one patient (3.7%) in the gel-EUS group and seven patients (13.4%) in the conventional EUS group; the single aspiration event in the gel-EUS group occurred before gel infusion. There were no significant differences between the groups in oxygen use, minimum oxygen saturation, or minimum systolic blood pressure.
Outcome measures
The primary outcome was the sensitivity of gel-based endoscopic ultrasonography (gel-EUS) for detecting pathological deep submucosal invasion (SM2 or deeper). Secondary outcomes included specificity, examination time, examination discontinuation rate, aspiration events, oxygen requirement, minimum oxygen saturation, minimum systolic blood pressure, and sedative medication dosage.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066504
