UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039326 |
|---|---|
| Receipt number | R000044848 |
| Scientific Title | Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/01/30 20:12:25 |
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Basic information
Public title
Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Acronym
Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Scientific Title
Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Scientific Title:Acronym
Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Epinephrine-added submucosal injection solution is used to facilitate hemostasis of non-variceal upper gastrointestinal bleeding and prevent delayed bleeding of large pedunculated colorectal lesions. However, its benefit on gastric endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is unclear and was examined here using propensity score-matching analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study was to clarify the benefit of the injection of epinephrine added solution into the submucosa during ESD in early gastric cancer.
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
Patients who are indicated for gastric ESD
Key exclusion criteria
adenoma
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Noriya |
| Middle name | |
| Last name | Uedo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
(+81)6-(6945)-1181
noriya.uedo@gmail.com
Public contact
Name of contact person
| 1st name | Shuntaro |
| Middle name | |
| Last name | Inoue |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
06-(6945)-1181
Homepage URL
inoue.shuntarou@gmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
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
Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
Tel
(+81) 6-(6945)-1181
rinri01@opho.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
| 2020 | Year | 02 | 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
1599
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
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 01 | Month | 28 | Day |
Other
Other related information
In total, 1,599 patients with solitary EGCs (83 patients treated with non-epinephrine added solution: non-epinephrine group and 1,516 patients treated with epinephrine-added solution: epinephrine group) were enrolled in this study between 2011 and 2018.
Management information
Registered date
| 2020 | Year | 01 | Month | 30 | Day |
Last modified on
| 2020 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044848
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
