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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025607
Receipt No. R000029468
Scientific Title Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs -a prospective study-
Date of disclosure of the study information 2017/01/16
Last modified on 2019/07/16

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Basic information
Public title Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs
-a prospective study-
Acronym Efficacy of third look endoscopy to prevent delayed bleeding after gastric ESD in patients with antithrombotic drugs
Scientific Title Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs
-a prospective study-
Scientific Title:Acronym Efficacy of third look endoscopy to prevent delayed bleeding after gastric ESD in patients with antithrombotic drugs
Region
Japan

Condition
Condition early gastric cancer / adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Overall delayed bleeding rate after ESD
Key secondary outcomes early phase delayed bleeding rate after ESD
late phase delayed bleeding rate after ESD
Clinicopathological features

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To perform 3rd-look endoscopy 5days later after ESD
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)patients with histological diagnosis as gastric adenocarcinoma or adenoma
(2)patients without history of gastrectomy or esophagectomy
(3)patients with antithrombotic agents regardless of drug withdrawal
(4)PS(ECOG)0,1,2
(5) patients who can be followed up more than 28days after ESD
(6)patients with written informed consent of this study
Key exclusion criteria (1) Patient with severe infection
(2) Patient who are pregnant, may be pregnant, or prefer pregnancy during treatment
(3)for Mental disease, dementia,it is difficult to participate study
(4) Patient with unstable angina, or myocardial infarction within 6 months.
(5)Patient with respiratory diseases requiring continuous oxygen therapy
(6)Patient with uncontrollable hypertension
(7)Patient with uncontrollable Diabetes
(8)anemia requiring transfusion(Hb<7.0g/dl), Easy to bleed for low platelet (Plt<50000)
(9) Patient judged inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kingo
Middle name
Last name hirasawa
Organization Yokohama City University Medical Center
Division name Division of Endoscopy
Zip code 232-0024
Address 4-57, urahunecho, minami ward, Yokohama city, Kanagawa Prefecture
TEL 0452615656
Email ryosuke@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Kingo
Middle name
Last name hirasawa
Organization Yokohama City University Medical Center
Division name Division of Endoscopy
Zip code 232-0024
Address 4-57, urahunecho, minami ward, Yokohama city, Kanagawa Prefecture
TEL 0452615656
Homepage URL
Email ryosuke@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Yokohama City University Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization institutional review board of Yokohama City University
Address 3-9, fukuura, kanazawa ward, Yokohama city, Kanagawa Prefecture
Tel 045-370-7627
Email rinri@yokohama-cu.ac.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 横浜市立大学附属市民総合医療センター
Yokohama City University Medical Center

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 16 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 16 Day
Date of IRB
2016 Year 12 Month 22 Day
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 10 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029468

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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