UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012451 |
|---|---|
| Receipt number | R000014568 |
| Scientific Title | Study about the influence to the gastric bleeding after the gastric endoscopic submucosal dissection (ESD) of the time to do the second-look endoscopy. |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2013/12/01 17:34:16 |
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Basic information
Public title
Study about the influence to the gastric bleeding after the gastric endoscopic submucosal dissection (ESD) of the time to do the second-look endoscopy.
Acronym
Necessity of second-look endoscopy after gastric endoscopic submucosal dissection (ESD).
Scientific Title
Study about the influence to the gastric bleeding after the gastric endoscopic submucosal dissection (ESD) of the time to do the second-look endoscopy.
Scientific Title:Acronym
Necessity of second-look endoscopy after gastric endoscopic submucosal dissection (ESD).
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the necessity of second-look endoscopy on the next day of gastric endoscopic submucosal dissection (ESD) to bleeding after ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bleeding rate after ESD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
A second-look endoscopy will not be performed on next day after ESD, but will be performed on 6th day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) One lesion of early gastric cancer or gastric adenoma.
2) Aged 20 years old or over.
3) With written informed consent.
Key exclusion criteria
1) Systemic administration of NSAIDs, corticosteroid, antiplatelet agent, or anticoagulant agent.
2) The diameter of a tumor is 5 cm or more.
3) History of gastrectomy or vagus nerve separation.
4) With the warning views on vomiting, gastrointestinal bleeding, rapid weight loss, etc.
5) With alcohol dependence or drug addiction.
6) Wit critical hormone abnormalities, such as hyperthyroidism.
7) With critical heart, liver and renal dysfunction, or a hematopoietic disorder.
8) With an allergy to medication (PPI).
9) Pregnant or lactation woman.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikako Tokoro |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Gastroenterology
Zip code
Address
3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL
045-832-1111
c-tokoro@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikako Tokoro |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Gastroenterology
Zip code
Address
3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL
045-832-1111
Homepage URL
c-tokoro@umin.ac.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Nanbu 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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 01 | Day |
Last modified on
| 2013 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014568
