UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042877 |
|---|---|
| Receipt number | R000048939 |
| Scientific Title | The usefulness of ultrasound/ultrasound endoscopy in the diagnosis of portal vein thrombosis/tumor thrombus |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2020/12/30 13:52:50 |
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Basic information
Public title
The usefulness of ultrasound/ultrasound endoscopy in the diagnosis of portal vein thrombosis/tumor thrombus
Acronym
Clinical study on portal vein thrombosis/tumor thrombus diagnosis
Scientific Title
The usefulness of ultrasound/ultrasound endoscopy in the diagnosis of portal vein thrombosis/tumor thrombus
Scientific Title:Acronym
Clinical study on portal vein thrombosis/tumor thrombus diagnosis
Region
| Japan |
Condition
Condition
Patients with suspected portal vein thrombosis or tumor thrombus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the diagnostic performance of extracorporeal ultrasound and ultrasound endoscopy for portal vein thrombosis and tumor thrombus based on the results of contrast-enhanced CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of diagnostic performance of portal vein thrombosis/tumor thrombus between extracorporeal ultrasound and ultrasound endoscopy
Key secondary outcomes
Comparison of the ability to differentiate between portal vein thrombosis and tumor thrombus using sonazoid
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound/Ultrasound endoscopy
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 suspected portal vein thrombosis or tumor thrombus
2) 20 years of age or older
3) Patients who have received sufficient explanation and understanding of the study and have given their free written consent to participate in the study.
Key exclusion criteria
1) Patients who are allergic to eggs and ineligible for sonazoid administration.
2) Pregnant women, lactating women, and women who may become pregnant or intend to become pregnant (if pregnancy is suspected, a pregnancy test should be performed).
3) Other patients whose safety may be compromised in the conduct of this study, or who are judged to have difficulty complying with the study protocol.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kato |
| Middle name | |
| Last name | Naoya |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL
0432227171
takakon@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kondo |
| Middle name | |
| Last name | Takayuki |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL
0432227171
Homepage URL
takakon@chiba-u.jp
Sponsor or person
Institute
Chiba Universtiy
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Chiba University Graduate School of Medicine, IRB
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
Tel
0432227171
inohana-rinri@chiba-u.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
| 2021 | Year | 01 | Month | 04 | 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
| 2020 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 12 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048939
