UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017078 |
|---|---|
| Receipt number | R000019450 |
| Scientific Title | Evaluation of safety of endoscopic submucosal dissection for gastric neoplasms without discontinuation of thienopyridine derivatives. |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2016/11/29 14:31:08 |
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Basic information
Public title
Evaluation of safety of endoscopic submucosal dissection for gastric neoplasms without discontinuation of thienopyridine derivatives.
Acronym
Gastric ESD on thienopyridines study.
Scientific Title
Evaluation of safety of endoscopic submucosal dissection for gastric neoplasms without discontinuation of thienopyridine derivatives.
Scientific Title:Acronym
Gastric ESD on thienopyridines study.
Region
| Japan |
Condition
Condition
Gastric neoplasms
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate safety of gastric ESD without discontinuation of thienopyridine derivatives.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post operative bleeding rate
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic submucosal dissection
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as or suspicious of gastric adenoma/adenocarcinoma (cStageIA).
2) More than six months after last PCI.
3) An oral administration of clopidogrel or prasugrel.
4) A treatment for a single lesion.
5) Older than 19 years and younger than 85 years.
6) Performance status of 0-2.
7) Normal liver, renal, and hematological functions.
8) Follow-up of 60 days after treatment.
9) Written informed consent.
Key exclusion criteria
1) Double registration.
2) A past history of coronary stent embolism.
3) A stent located in left main coronary trunk.
4) A past history of irradiation in upper abdomen.
5) A plan of following treatment for esophageal or duodenal lesions.
6) A recent treatment for upper GI lesions within 28 days before registration.
7) A plan of following treatment for upper GI lesions within 28 days after treatment.
8) A systemic administration of steroids or anticoagulants.
9) An administration of NSAID or other antiplatelets that can be withdrawn before treatment.
10) Pregnancy or bleastfeeding.
11) An active bacterial or fungal infection.
12) A poor control of hypertension.
13) A severe respiratory disease.
14) Other conditions that are judged not suitable.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL
03-3815-5411
satoshi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo.
TEL
03-3815-5411
Homepage URL
satoshi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019450
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| Registered date | File name |
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| Registered date | File name |
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