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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020319
Receipt No. R000021038
Scientific Title Evaluation of usefulness of coiling embolization for isolated gastric varices with ultrasonic endoscope
Date of disclosure of the study information 2015/12/24
Last modified on 2020/06/27

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Basic information
Public title Evaluation of usefulness of coiling embolization for isolated gastric varices with ultrasonic endoscope
Acronym Usefulness of coiling embolization for gastric varices with ultrasonic endoscope
Scientific Title Evaluation of usefulness of coiling embolization for isolated gastric varices with ultrasonic endoscope
Scientific Title:Acronym Usefulness of coiling embolization for gastric varices with ultrasonic endoscope
Region
Japan

Condition
Condition Isolated gastric varices
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness and safety of coiling embolization for isolated gastric varices with ultrasonic endoscope
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Feasibility
2. Efficacy
3. Safety (complication)
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Coil deployment in the gastric varices
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. Patient who has isolated gastric varices with red color sign and/or erosion and/or large varices.
2. Patient who has bleeding history from varices.
3. Patients of age =>20.
4. Patients who understand and are willing to give a written informed consent about participation
Key exclusion criteria 1. Patients in ECOG performance status 4.
2. Patient who has other severe disease (> ASA3)
3. Pregnant patient (including suspision)
4. PLT count less than 50,000, PT-INR more than 2.
5. Patient with portal thrombosis.
6. diffuse type gastric varices
7. Technical difficulty for approaching to the gastric varices using EUS
8. Patient who has esophagogastrointestinal strictures.
9. Patients considered ineligible for this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Fuminori
Middle name
Last name Moriyasu
Organization Tokyo Medical University Hospital
Division name Gastroenterology and Hepatology
Zip code 160-0023
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 0333426111
Email moriyasu@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Furuichi
Organization Tokyo Medical University Hospital
Division name Gastroenterology and Hepatology
Zip code 160-0023
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 0333426111
Homepage URL
Email furuichi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization Tokyo Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical University
Address 6-7-1 Nishishinjuku Shinjuku Tokyo Japan
Tel 0333426111
Email furuichi@tokyo-med.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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 24 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 Terminated
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
2015 Year 04 Month 28 Day
Anticipated trial start date
2015 Year 12 Month 24 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 24 Day
Last modified on
2020 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021038

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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