UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057160 |
|---|---|
| Receipt number | R000065341 |
| Scientific Title | Comparison of Suture Techniques in Endoscopic Hand Suturing (EHS) After Gastric ESD: A Retrospective Analysis |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/02/27 20:34:11 |
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Basic information
Public title
Comparison of Suture Techniques in Endoscopic Hand Suturing (EHS) After Gastric ESD: A Retrospective Analysis
Acronym
EHS technique study
Scientific Title
Comparison of Suture Techniques in Endoscopic Hand Suturing (EHS) After Gastric ESD: A Retrospective Analysis
Scientific Title:Acronym
EHS technique study
Region
| Japan |
Condition
Condition
Gastric neoplasma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic submucosal dissection (ESD) is a standard treatment for early gastric carcinoma; however, large mucosal defects increase the risk of complications such as perforation and postoperative bleeding. Endoscopic hand suturing (EHS) is a promising technique for defect closure, but the optimal suturing method remains unclear. This study aimed to compare the effectiveness of three EHS techniques, single, layered, and double sutures in maintaining suture integrity and improving clinical outcomes. We hypothesized that layered and double sutures would result in superior suture retention compared to single sutures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was suture maintenance rate on day 6.
Key secondary outcomes
The secondary outcomes included suture time, number of sutures, complications, suture speed (resection area/suture time), and ROC analysis to determine the optimal cutoff value for dehiscence risk.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study was conducted on patients aged 20 years or older who underwent endoscopic submucosal dissection (ESD) for gastric tumors at our hospital.
Key exclusion criteria
Patients with sutures in the duodenal bulb and those who did not undergo endoscopy on the sixth day were excluded.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki harbor medical center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
taku.okamu1002@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
Homepage URL
taku.okamu1002@gmail.com
Sponsor or person
Institute
Nagasaki harbor Medical Center Research and Development Center
Institute
Department
Personal name
Takuma Okamura
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 Research and Development Center
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
Tel
0958223251
kenkyu@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 | 02 | Month | 27 | 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
62
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection and evaluation items
Demographic and clinical data such as age, sex, and lesion location, procedural parameters such as suture technique, suture time, number of sutures, and suture speed were collected from electronic medical records. Postoperative outcomes such as suture maintenance rate on day 6, and complications were also evaluated. The primary outcome was suture maintenance rate on day 6. The secondary outcomes included suture time, number of sutures, complications, suture speed (resection area/suture time), and ROC analysis to determine the optimal cutoff value for dehiscence risk.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065341
