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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013177
Receipt No. 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

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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
Email 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
Email cancer@gol.com

Sponsor
Institute Multicenter randomized control study in patients with LDA during gastric ESD
Institute
Department

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
Email 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
URL(English) 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


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