UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061924 |
|---|---|
| Receipt number | R000069512 |
| Scientific Title | Multicenter Observational Study Evaluating the Feasibility and Safety of Clinical Introduction of Endoscopic Hand Suturing Following Standardized Training |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/16 05:43:25 |
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Basic information
Public title
Multicenter Observational Study Evaluating the Feasibility and Safety of Clinical Introduction of Endoscopic Hand Suturing Following Standardized Training
Acronym
EHS-SuTURE Study
Scientific Title
Multicenter Observational Study Evaluating the Feasibility and Safety of Clinical Introduction of Endoscopic Hand Suturing Following Standardized Training
Scientific Title:Acronym
EHS-SuTURE
Region
| Japan |
Condition
Condition
Early Gastric Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clinical feasibility and safety of Endoscopic Hand Suturing (EHS) in clinical cases after the implementation of a standardized EHS training system. The primary endpoint is the completion rate of EHS. Secondary endpoints include suturing time, number of stitches, suturing time per stitch, sustained closure rate, post-procedural bleeding rate, complication rate, adverse event rate, and location-specific technical difficulty.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate of EHS .
Key secondary outcomes
Secondary endpoints are suturing time, number of stitches, suturing time per stitch, sustained closure rate, post-procedural bleeding rate, complication rate, adverse event rate, and location-specific technical difficulty.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Gastric tumor <30 mm in size
2.Scheduled for ESD at the study institution
3.Age >=20 years
4.ECOG performance status 0-1
5.Written informed consent obtained from the patient
Key exclusion criteria
1.Early gastric cancer arising in the remnant stomach after gastrectomy (including remnant gastric cancer and gastric conduit cancer)
2.Tumors adjacent to the cardia or pylorus, or crossing the gastric angle
3.Bleeding tendency defined as platelet count <50000/mm3 or PT-INR >=2 (excluding patients receiving warfarin therapy)
4.Liver cirrhosis classified as Child-Pugh class B or C
5.Chronic renal failure requiring maintenance dialysis
6.Any cases deemed inappropriate for study participation by the investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Morita |
Organization
Omuta city hospital
Division name
Division of Gastroenterology
Zip code
8368567
Address
2-19-1 Takarazaka-machi, Omuta, Fukuoka 836-8567, Japan
TEL
+81-944-53-1061
morita_taku@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Morita |
Organization
Omuta city hospital
Division name
Division of Gastroenterology
Zip code
836-8567
Address
2-19-1 Takarazaka-machi, Omuta, Fukuoka 836-8567, Japan
TEL
+81-944-53-1061
Homepage URL
morita_taku@kurume-u.ac.jp
Sponsor or person
Institute
Omuta city hospital
Institute
Department
Personal name
Funding Source
Organization
Omuta city hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NTT Medical Center Tokyo (Tokyo), Japanese Red Cross Omori Hospital (Tokyo), Itabashi Chuo Medical Center (Tokyo)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omuta city hospital
Address
2-19-1 Takarazaka-machi, Omuta, Fukuoka 836-8567, Japan
Tel
+81-944-53-1061
omuta_yuku@ghp.omuta.fukuoka.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 | 06 | Month | 30 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study. Eligible patients are those who are scheduled to undergo ESD for gastric tumors at participating institutions between March 1, 2024 and December 31, 2025, meet the inclusion criteria, and provide written informed consent. Six physicians with fewer than five clinical EHS cases will undergo preclinical training using SuTURE mounted on the G-Master ESD training system. EHS will then be performed for post-ESD mucosal defects after ESD for gastric tumors smaller than 30 mm. The target sample size is 60 patients, with a target of 10 cases per physician.
The primary endpoints are the EHS completion rate and suturing time. Secondary endpoints include suture retention rate, postprocedural bleeding rate, minor postprocedural bleeding rate, number of stitches per ulcer floor area, complication rate, mean bite and pitch, and technical difficulty according to lesion location. Safety endpoints include the incidence, severity, outcome, and causal relationship of adverse events. The clinical information to be collected includes age, sex, height, body weight, medical history, past history, treatment history, laboratory data, endoscopic images, adverse events, EHS completion rate, and suturing time.
Management information
Registered date
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069512
