UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044857 |
|---|---|
| Receipt number | R000051239 |
| Scientific Title | Examination of the ultrasonic image of thoracic duct in patients with liver disease |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/01/14 19:37:25 |
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Basic information
Public title
Examination of the ultrasonic image of thoracic duct in patients with liver disease
Acronym
Examination of the ultrasonic image of thoracic duct in patients with liver disease
Scientific Title
Examination of the ultrasonic image of thoracic duct in patients with liver disease
Scientific Title:Acronym
Examination of the ultrasonic image of thoracic duct in patients with liver disease
Region
| Japan |
Condition
Condition
liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, it is known that thoracic duct become thick depending on the progression of liver disease, and the observation of the thoracic duct as the condition in the liver disease is gathering attention. Conventionally, MRI has been used for thoracic duct observation, but ultrasonography can
depict it, too. We aim to clarify the effectiveness of ultrasonography in the thoracic duct to evaluate the liver disease condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the thoracic duct diameter which is measured by ultrasonography and MRI.
Key secondary outcomes
Examination of the correlation of thoracic duct diameter and portal hypertension. Examination of the correlation of the thoracic duct diameter and ascites. Examination of the correlation of the thoracic duct diameter and liver tissue.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Chronic hepatitis, and cirrhosis. Performance status(ECOG) is 0 or 1.
Key exclusion criteria
The person who can not keep rest because of dementia. The person who is contraindicated to MRI. The person who merges a disease resulting in anasarca other than liver disease. The person during the pregnancy or with the possibility of the pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hiasa |
Organization
Ehime University of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
Ehime University of Medicine main building F8,454 Shizugawa,Touon city,Ehime Prefecture
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Hirooka |
Organization
Ehime University of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
Ehime University of Medicine main building F8,454 Shizugawa,Touon city,Ehime Prefecture
TEL
089-960-5308
Homepage URL
masashih@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.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
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37500943/
Number of participants that the trial has enrolled
138
Results
A scatter plot of HVPG and thoracic duct diameter classified patients into two groups: one with a strong positive correlation (r = 0.662) and another with HVPG elevation despite duct narrowing, often associated with refractory ascites. Adding thoracic duct diameter to the Baveno VII criteria maintained CSPH diagnostic accuracy while reducing unclassified cases from 68 to 18.
Results date posted
| 2025 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 17 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The design is a crossing study. The subject is the patient who meet criteria for selection and who is admitted to our facilities from June 29, 2021 to March 31, 2025.
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051239
