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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019386
Receipt No. R000022420
Scientific Title Utility of autologous fibrin glue for prevention of delayed bleeding of gastric endoscopic submucosal dissection under antithrombotic therapy
Date of disclosure of the study information 2015/10/16
Last modified on 2015/10/16

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Basic information
Public title Utility of autologous fibrin glue for prevention of delayed bleeding of gastric endoscopic submucosal dissection under antithrombotic therapy
Acronym T-HOPE 1306
Scientific Title Utility of autologous fibrin glue for prevention of delayed bleeding of gastric endoscopic submucosal dissection under antithrombotic therapy
Scientific Title:Acronym T-HOPE 1306
Region
Japan

Condition
Condition Gastric neoplasms
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the utility of autologous fibrin glue for prevention of gastric ESD under antithrombotic therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of delayed bleeding
Key secondary outcomes adverse event of autologous fibrin glue
rate of allogeanic blood transfusion
rate of autologous blood transfusion
condition of ESD ulcer and fibrin glue on 1POD, 7POD, and 8 week.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 autologous fibrin glue
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 over 20 years old
2. patients with gastric neoplasms indicated for the treatment of ESD
3. patients under antithrombotic therapy
4. patients with written informed consent
Key exclusion criteria 1. Hb<11g/dl
2. patients with active infections disease
3. patients under severe dehydration condition
4. patients with allergy for bovine product
5. patients taking antiplasmin agent
6. Patients were excluded if they were considered inappropriate for participation in this study by their attending physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Kaise
Organization Toranomon hospital
Division name Department of gastroenterology
Zip code
Address 2-2-2 toranomon, minato-ku, tokyo
TEL +81-33588-1111
Email dkiku1230@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Kikuchi
Organization Toranomon hospital
Division name Department of gastroenterology
Zip code
Address 2-2-2 toranomon, minato-ku, tokyo
TEL +81-33588-1111
Homepage URL
Email dkiku1230@gmail.com

Sponsor
Institute Toranomon hospital
Institute
Department

Funding Source
Organization non
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
Email

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 10 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 Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 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
2015 Year 10 Month 16 Day
Last modified on
2015 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022420

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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