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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042877
Receipt No. 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

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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
Email 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
Email takakon@chiba-u.jp

Sponsor
Institute Chiba Universtiy
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048939

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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