UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057952 |
|---|---|
| Receipt number | R000066242 |
| Scientific Title | Evaluation of the learning curve for endoscopic hand-suturing after gastric endoscopic submucosal dissection |
| Date of disclosure of the study information | 2025/05/24 |
| Last modified on | 2025/05/23 21:38:13 |
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Basic information
Public title
Evaluation of the learning curve for endoscopic hand-suturing in the closure of mucosal defects after gastric endoscopic resection
Acronym
Evaluation of the learning curve for endoscopic hand-suturing in the closure of mucosal defects after gastric endoscopic resection
Scientific Title
Evaluation of the learning curve for endoscopic hand-suturing after gastric endoscopic submucosal dissection
Scientific Title:Acronym
Evaluation of the learning curve for endoscopic hand-suturing after gastric endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Patients who underwent endoscopic hand-suturing for wound closure after gastric endoscopic submucosal dissection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the learning curve for endoscopic hand-suturing in the closure of mucosal defects after gastric endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average time per stitch
Key secondary outcomes
Suture retention rate, Postoperative complication rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients admitted to the Department of Gastroenterology at our hospital between November 1, 2022, and March 31, 2025.
(ii) Target condition: Cases in which a single expert performed endoscopic hand-suturing (EHS) for wound closure after gastric endoscopic submucosal dissection (ESD).
(iii) Age: Patients aged 18 years or older.
(iv) Sex: No restrictions.
(v) Patients who provided informed consent to participate in this study.
Key exclusion criteria
(i) Cases in which endoscopic hand-suturing (EHS) was performed by someone other than the designated expert.
(ii) Cases where the suture site involved organs other than the stomach.
(iii) Cases in which two endoscopes were used during EHS.
(iv) Other patients deemed inappropriate for inclusion in the study by the investigators.
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | Tomonari |
| Middle name | |
| Last name | Ikeda |
Organization
Nagasaki Harbor Medical Center
Division name
Division of Gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-machi, Nagasaki-shi, Nagasaki, Japan
TEL
095-822-3251
ikeda_tomonari@ncho.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Ikeda |
Organization
Nagasaki harbor medical center
Division name
Division of Gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-machi, Nagasaki-shi, Nagasaki, Japan
TEL
095-822-3251
Homepage URL
ikeda_tomonari@ncho.jp
Sponsor or person
Institute
Nagasaki harbor medical center
Institute
Department
Personal name
Tomonari Ikeda
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki harbor medical center
Address
6-39 Shinchi-machi, Nagasaki-shi, Nagasaki, Japan
Tel
095-822-3251
ikeda_tomonari@ncho.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 | 05 | Month | 24 | 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
59
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
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066242
