UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000021038