UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016614 |
|---|---|
| Receipt number | R000019282 |
| Scientific Title | A comparative randomized trial of pre-emptive dexamethasone for relief of pain after endoscopic submucosal dissection for early gastric neoplasm |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2015/02/23 20:02:06 |
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Basic information
Public title
A comparative randomized trial of pre-emptive dexamethasone for relief of pain after endoscopic submucosal dissection for early gastric neoplasm
Acronym
A comparative randomized trial of pre-emptive dexamethasone for relief of pain after endoscopic submucosal dissection for early gastric neoplasm
Scientific Title
A comparative randomized trial of pre-emptive dexamethasone for relief of pain after endoscopic submucosal dissection for early gastric neoplasm
Scientific Title:Acronym
A comparative randomized trial of pre-emptive dexamethasone for relief of pain after endoscopic submucosal dissection for early gastric neoplasm
Region
| Asia(except Japan) |
Condition
Condition
early gastric neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical effect of the pre-emptive and postoperative dexamethasone on pain after ESD for early gastric neoplasm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Present pain intensity
Key secondary outcomes
Short-form McGill pain (SF-MP) categories for immediate and 6-, 12-, and 24-h postoperative periods
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous 0.15 mg/kg dexamethasone before ESD and placebo after ESD
Interventions/Control_2
Placebo before ESD and intravenous 0.15 mg/kg dexamethasone after ESD
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20 years of age or older
2) pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
3) patients who gave written informed consent from patients or responsible family members.
Key exclusion criteria
1) patients who take pain killer within 48 hours or regularly at enrollment
2) confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
3) multiple gastric lesions for ESD
4) history of gastric surgery at enrollment
5) severe underlying disease including infection, cardiopulmonary disease, and diabetes.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hyuk Lee |
Organization
Samsung Medical Center
Division name
Department of Medicine
Zip code
Address
Ilwon-dong 50, Gangnam-gu
TEL
82-2-3410-3409
leehyuk@skku.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyuk Lee |
Organization
Samsung Medical Center
Division name
Department of Medicine
Zip code
Address
Ilwon-dong 50, Gangnam-gu
TEL
82-2-3410-3409
Homepage URL
leehyuk@skku.edu
Sponsor or person
Institute
Hyuk Lee
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
Samsung Medical Center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 23 | Day |
Last modified on
| 2015 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019282
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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