UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058659 |
|---|---|
| Receipt number | R000066994 |
| Scientific Title | Complication prevention measures for high-risk cases of stricture after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/29 09:35:48 |
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Basic information
Public title
Complication prevention measures for high-risk cases of stricture after endoscopic submucosal dissection
Acronym
Complication prevention measures for high-risk cases of stricture after endoscopic submucosal dissection
Scientific Title
Complication prevention measures for high-risk cases of stricture after endoscopic submucosal dissection
Scientific Title:Acronym
Complication prevention measures for high-risk cases of stricture after endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
stomach cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to clarify the current status of stenosis after gastric ESD at our hospital and the usefulness of concomitant steroid use, and to consider treatment strategies for high-risk cases of stenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usefulness of steroid administration for patients at high risk of stenosis after gastric endoscopic submucosal dissection
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
Between April 1, 2004 and June 30, 2024, 1,207 cases of ESD were performed for gastric epithelial and submucosal tumors at our hospital.
Of these, 148 cases were cardia and pylorus cases, and 3 cases in which the progress could not be followed were excluded, so 145 cases were examined.
Key exclusion criteria
Cases in which the presence or absence of stenosis after ESD could not be confirmed
Target sample size
145
Research contact person
Name of lead principal investigator
| 1st name | Shuntaro |
| Middle name | |
| Last name | Uno |
Organization
Tobata Kyoritsu Hospital
Division name
Gastroenterology
Zip code
804-0093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu City, Fukuoka Prefecture
TEL
093-871-5421
unodostres1228@icloud.com
Public contact
Name of contact person
| 1st name | Shuntaro |
| Middle name | |
| Last name | Uno |
Organization
Tobata Kyoritsu Hospital
Division name
Gastroenterology
Zip code
804-0093
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu City, Fukuoka Prefecture
TEL
093-871-5421
Homepage URL
unodostres1228@icloud.com
Sponsor or person
Institute
Tobata Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Tobata Kyoritsu Hospital
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
Tobata Kyorutsu Hospiral Ethics Review Committee
Address
2-5-1 Sawami, Tobata-ku, Kitakyushu City, Fukuoka Prefecture
Tel
093-871-5421
unodostres1228@icloud.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
| 2025 | Year | 08 | Month | 01 | 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
145
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 | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | 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
Nothing in particular
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066994
