UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013177 |
|---|---|
| Receipt number | R000015365 |
| Scientific Title | Acute and delayed bleeding risk of endoscopic submucosal dissection for gastric neoplasia in patients with low-dose aspirin administration-multicenter randomized control study- |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2022/08/24 19:13:12 |
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Basic information
Public title
Acute and delayed bleeding risk of endoscopic submucosal dissection for gastric neoplasia in patients with low-dose aspirin administration-multicenter randomized control study-
Acronym
Multicenter randomized control study for bleeding risk related with LDA during gastric ESD
Scientific Title
Acute and delayed bleeding risk of endoscopic submucosal dissection for gastric neoplasia in patients with low-dose aspirin administration-multicenter randomized control study-
Scientific Title:Acronym
Multicenter randomized control study for bleeding risk related with LDA during gastric ESD
Region
| Japan |
Condition
Condition
Gastric neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this multicenter randomized control study is to evaluate whether low-dose aspirin continuous administration does not increase bleeding risk related with ESD for gastric neoplasia in patients with low-risk of thrombo-embolism.
Basic objectives2
Others
Basic objectives -Others
non-inferiority trial
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence rate of active bleeding during ESD and delayed bleeding post ESD in patients with gastric neoplasia
Key secondary outcomes
incidence of cerebrovascular event, healing status of mucosal defect after ESD, incidence of any adverse events, incidence of adverse event related with ESD, treatment time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
low-dose aspirin continuous administration
Interventions/Control_2
low-dose aspirin withdrawal
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
Diagnosed ad gastric adenoma or gastric cancer estimated as clinical stage IA endoscopically/Administrating low-dose aspirin/More than 9.0d/dl Hb level on the laboratory data within 28 days before ESD/Physical status;0-2/Accepted to enrollment and registration for this randomized study
Key exclusion criteria
Subject with difficult agreement of enrollment and registration for this randomized study/Ineligible subjects certified by doctors
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Gotoda |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-972-8111
takujigotoda@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541- 0042, Japan
TEL
06-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Multicenter randomized control study in patients with LDA during gastric ESD
Institute
Department
Personal name
Funding Source
Organization
The Japanese foundation for research and promotion of endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases
Name of secondary funder(s)
Nihon University School of Medicine
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
Chiyoda-ku, Kanda, Surugadai 1-6
Tel
03-3293-1711
takujigotoda@yahoo.co.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
大阪府立成人病センター（大阪）、日本大学病院（東京）、自治医科大学附属病院（栃木）、佐賀大学医学部附属病院（佐賀）、東京大学医学部附属病院（東京）、徳島大学病院（徳島）、広島大学病院（広島）、岩手医科大学病院（岩手）、国立がん研究センター中央病院（東京）、三重大学病院（三重）、仙台市医療センター仙台オープン病院（宮城）、石川県立中央病院（石川）、新潟県立中央病院（新潟）、斗南病院（北海道）、京都府立医科大学附属病院（京都）、兵庫医科大学病院（兵庫）、がん研有明病院（東京）、静岡県立静岡がんセンター（静岡）、京都武田病院（京都）、国立病院機構九州医療センター（福岡）、名古屋市立大学病院（愛知）、岡山大学病院（岡山）、手稲渓仁会病院（北海道）、大阪赤十字病院（大阪）、弘前大学大学院医学研究科（青森）、岩手県立胆沢病院（岩手）、埼玉医科大学国際医療センター（埼玉）、東京女子医科大学病院（東京）、順天堂大学医学部附属順天堂医院（東京）、聖マリアンナ医科大学病院（東京）、琉球大学医学部附属病院（沖縄）、長崎大学病院（長崎）、鳥取赤十字病院（鳥取）、福島県立医科大学附属病院（福島）、市立四日市病院（三重）、福井県立病院（福井）、大垣市民病院（岐阜）、津山中央病院（岡山）、富山県立中央病院（富山）、広島市民病院（広島）、大分大学（大分）、愛知がんセンター（愛知）、山梨大学（山梨）、勤医協中央病院（北海道）、栃木県立がんセンター（栃木）、宝塚市立病院（兵庫）、由利組合総合病院（秋田）、金沢大学附属病院（石川）、富山大学附属病院（富山）、金沢医療センター（石川）、済生会福岡病院（福岡）、独立行政法人広島市立病院機構広島市立安佐市民病院（広島）、高松市民病院（香川）、独立行政法人国立病院機構 呉医療センター・中国がんセンター（広島）、兵庫県立がんセンター（兵庫）、パナソニック健康保険組合松下記念病院（大阪）、市立奈良病院（奈良）、大阪府済生会吹田病院（大阪）、京都第一赤十字病院（京都）、京都府立医科大学附属北部医療センター（京都）、日本赤十字社和歌山医療センター（和歌山）、王子総合病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
560
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 17 | Day |
Last modified on
| 2022 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015365
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/05/13 | SETUP protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/05/13 | 20210507.xlsx |
