UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020319 |
|---|---|
| Receipt number | 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 10:25:35 |
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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
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
furuichi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021038
