UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057582 |
|---|---|
| Receipt number | R000065791 |
| Scientific Title | Assessment of Lymphatic Drainage Capacity in Patients with Liver Disease Using Lipiodol |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2026/04/12 18:55:29 |
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Basic information
Public title
Assessment of Lymphatic Drainage Capacity in Patients with Liver Disease Using Lipiodol
Acronym
Assessment of Lymphatic Drainage Capacity in Patients with Liver Disease Using Lipiodol
Scientific Title
Assessment of Lymphatic Drainage Capacity in Patients with Liver Disease Using Lipiodol
Scientific Title:Acronym
Assessment of Lymphatic Drainage Capacity in Patients with Liver Disease Using Lipiodol
Region
| Japan |
Condition
Condition
Liver cirrhosis with ascites
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In liver cirrhosis, the progression of portal hypertension increases the risk of developing complications such as ascites, esophagogastric varices, and hepatic encephalopathy. Recent studies have suggested that lymphatic drainage function may decline as liver disease progresses, potentially worsening ascites; however, clear evidence supporting this in humans has not been established.
This study aims to clarify the relationship between portal hypertension and lymphatic drainage function by evaluating lymphatic flow through the injection of contrast medium into the inguinal lymph nodes of patients with liver cirrhosis and ascites.
Basic objectives2
Others
Basic objectives -Others
Mechanism clarification
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is to clarify the relationship between lymphatic drainage function and the severity of hepatic ascites.
Patients will be stratified into two groups based on their response to diuretics: a non-refractory ascites group (ascites improved with diuretics) and a refractory ascites group (ascites not improved despite diuretic treatment).
The contrast agent inflow velocity was compared between the groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with liver cirrhosis and ascites will undergo lymphangiography once during hospitalization. A total of 10 mL of Lipiodol will be injected into the right inguinal lymph node. After completion of the injection, X-ray imaging will be performed at 10-minute intervals to measure the time required for the contrast agent to reach the terminal thoracic duct. Lymphatic drainage function (contrast inflow velocity) is calculated by dividing the distance between the inguinal lymph node and the terminal thoracic duct by the time it takes for the contrast agent to reach the terminal thoracic duct. This intervention will be performed only once, with no additional injections or repeated procedures.
Interventions/Control_2
Patients with liver cirrhosis and ascites will undergo lymphangiography once during hospitalization. A total of 10 mL of Lipiodol will be injected into the right inguinal lymph node. After completion of the injection, X-ray imaging will be performed at 10-minute intervals to measure the time required for the contrast agent to reach the terminal thoracic duct. Lymphatic drainage function (contrast inflow velocity) is calculated by dividing the distance between the inguinal lymph node and the terminal thoracic duct by the time it takes for the contrast agent to reach the terminal thoracic duct. This intervention will be performed only once, with no additional injections or repeated procedures.
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
Patients aged 20 years or older with liver cirrhosis who have a history of hepatic ascites and currently have persistent ascites. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. No restrictions regarding sex.
Key exclusion criteria
Patients who are unable to remain at rest during the procedure. Patients with contraindications to iodinated contrast agents. Patients with comorbid conditions other than liver disease that may cause systemic edema, such as heart failure with BNP >= 100 pg/mL or renal disease with proteinuria (>= 3+) or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2. Pregnant women or patients who may be pregnant.
Target sample size
40
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
Funding Source: None
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
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
| 2025 | Year | 04 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The interim analysis is planned once the target number of cases is reached; the required number has not been reached at present.
Management information
Registered date
| 2025 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065791
