UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013297 |
|---|---|
| Receipt number | R000015444 |
| Scientific Title | A comparison of delayed bleeding associated with endoscopic submucosal dissection for gastric neoplasms between solid and liquid diet |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2018/12/18 04:46:38 |
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Basic information
Public title
A comparison of delayed bleeding associated with endoscopic submucosal dissection for gastric neoplasms between solid and liquid diet
Acronym
ESD Asahi Trial (EAT)
Scientific Title
A comparison of delayed bleeding associated with endoscopic submucosal dissection for gastric neoplasms between solid and liquid diet
Scientific Title:Acronym
ESD Asahi Trial (EAT)
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the establishment of the way to ingest after ESD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
delayed bleeding rate
Key secondary outcomes
1.the rate of ulcer scar about 4 weeks after ESD(evaluate by Sakita classification)
2.the QOL changing between the date of admission and leave the hospital(evaluate by EORTC QLQ-C30 and EORTC QLQ-STO 22)
3.hospital charges
4.abdominal distension
5.abdominal pain
6.constipation
7.diarrhea
8.nausea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
solid diet
Interventions/Control_2
liquid diet
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with gastric neoplasms who underwent ESD
Key exclusion criteria
(1)patients with use of antiplatelet agents(aspirin, thienopyridine derivative,and cilostazol) and anticoagulants
(2) patients who are pregnant or nursing
(3) patients with unstable mental condition
(4) patients with use of steroid drugs
(5) patients with bacterial and fungal infection
(6) patients who are diagnosed as unsuitable for this trial by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Miyakawa |
Organization
Asahi General Hospital
Division name
Department of Gastroenterology
Zip code
Address
1326, I, Asahi ,Chiba, Japan
TEL
0479-63-8111
a292miyaka2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Miyakawa |
Organization
Asahi General Hospital
Division name
Department of Gastroenterology
Zip code
Address
1326, I, Asahi ,Chiba, Japan
TEL
0479-63-8111
Homepage URL
a292miyaka2007@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Asahi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi General 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
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.karger.com/Article/FullText/494490
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 12 | 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
| 2014 | Year | 02 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015444
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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