UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008078 |
|---|---|
| Receipt number | R000009510 |
| Scientific Title | Noninvasive Evaluation of Hepatic Hemodynamics Using Xe Computed Tomography |
| Date of disclosure of the study information | 2012/06/02 |
| Last modified on | 2023/01/05 07:12:55 |
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Basic information
Public title
Noninvasive Evaluation of Hepatic Hemodynamics Using Xe Computed Tomography
Acronym
Hepatic Hemodynamics Using Xe Computed Tomography
Scientific Title
Noninvasive Evaluation of Hepatic Hemodynamics Using Xe Computed Tomography
Scientific Title:Acronym
Hepatic Hemodynamics Using Xe Computed Tomography
Region
| Japan |
Condition
Condition
Liver disease (acute hepatitis, Chronic hepatitis, liver cirrhosis, hepatic failure, etc)
Liver tumor (hepatocellular carcinoma, cholangiocellular carcinoma, metastatic liver tumor, etc)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Xenon computed tomography (Xe-CT) is a convenient and noninvasive method combining xenon gas inhalation with CT to quantify and visualize tissue blood flow (TBF). Xe-CT is widely used in neurosurgical practice to evaluate cerebral TBF. The liver contains a dual blood supply system that includes the hepatic artery and portal vein, and Xe-CT using a dual blood supply model has been used to evaluate hepatic arterial TBF (HATBF) and portal venous TBF (PVTBF) separately. The present study evaluated the usefulness of Xe-CT as a noninvasive procedure for measuring HATBF, PVTBF and Xe solubility coefficient in patients with various liver disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. correlation between tissue blood flow and stage of fibrosis.
2. correlation between tissue blood flow and grade of Child-Pugh.
3. correlation between Xe solubility coefficient and stage of steatosis.
4. Alteration of tissue blood flow and Xe solubility coefficient before and after treatment (interferon, endoscopic procedure, operation, diet-exercise therapy, etc)
Key secondary outcomes
1. reproducibility
2. safety
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
1. Patients with liver disease, who can admit to our hospital
2. we used 25 % stable Xe gas in conjunction with an AZ-726 Xe gas inhalation system (Anzai Medical, Tokyo, Japan). The wash-in and wash-out periods were both 4 min. The entire liver was CT-scanned at 1-min intervals at 4 levels, including the porta hepatis (9 scans in total, including the baseline scan).
3. Using an AZ-7000W image processing system (Anzai Medical), each tissue blood flow and Xe solubility coefficient are calculated.
4. An Aquilion CT scanner (Toshiba Medical Systems, Tokyo, Japan) was used, with exposure factors of 120 kV, 300 mA, and 13.8 mGy.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients with liver disease or tumor
Key exclusion criteria
1. severe cardiac, renal and lung disease
2. consciouness distubance
3. severe allergy and asthma
4. pregnacy
5. Otherwise, in case that investigators judge the patient who is inappropriate for this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University, School of Medicine
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, 216-8511, Japan
TEL
+81-44-977-8111
hide-bo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Takahashi |
Organization
St. Marianna University, School of Medicine
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, 216-8511, Japan
TEL
+81-44-977-8111
Homepage URL
hide-bo@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University, School of Medicine, Department of Internal Medicine, Division of Gastroenterology & Hepatology
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University, School of Medicine, Department of Internal Medicine, Division of Gastroenterology & Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Anzai Medical Company Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University, School of Medicine,
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, 216-8511, Japan
Tel
+81-44-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Takahashi H, Shigefuku R et al J Gastroenterol 2013
Takahashi H, Shigefuku R et al World J Gastroenterol 2014
Shigefuku R Takahashi H, et al Int J Mol Sci 2014
Shigefuku R Takahashi H, et al Int J Mol Sci 2016
Shigefuku R Takahashi H, et al BMC Gastroetenrol 2022
Results date posted
| 2023 | Year | 01 | Month | 05 | Day |
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
| 2001 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2001 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2001 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Evaluation of tissue blood flow by stage of fibrosis
2. Evaluation of tissue blood flow by grade of Child-Pugh
3. Evaluation of Xe solubility coefficient by grade of steatosis
4. Evaluation of tissue blood flow by etiology
5. Evaluation of alteration of tissue blood flow and Xe solubility coefficient before and after treatment
Management information
Registered date
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009510
