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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008078
Receipt No. 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 2016/06/04

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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
Middle name
Last name Michihiro Suzuki
Organization St. Marianna University, School of Medicine
Division name Department of Internal Medicine, Division of Gastroenterology & Hepatology
Zip code
Address 2-16-1, Sugao, Miyamae, Kawasaki, 216-8511, Japan
TEL 044-977-8111
Email hide-bo@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Takahashi
Organization St. Marianna University, School of Medicine
Division name Department of Internal Medicine, Division of Gastroenterology & Hepatology
Zip code
Address 2-16-1, Sugao, Miyamae, Kawasaki, 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email hide-bo@marianna-u.ac.jp

Sponsor
Institute St. Marianna University, School of Medicine, Department of Internal Medicine, Division of Gastroenterology & Hepatology
Institute
Department

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
Address
Tel
Email

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
Sase S, Suzuki M, Ikeda H, et al. Quantitative multilevel mapping of hepatic blood flow by xenon computed tomography using the aorta. J Comput Assist Tomogr 2003; 27:647-651.

Ikeda H, Suzuki M, Takahashi H, et al. Hepatic blood flow measurement with arterial and portal blood flow by xenon computed tomography: Quantitative analysis of correlation with hepatic fibrosis in chronic hepatitis C. Hepatol Res 2007; 37:104-112.

Takahashi H, Suzuki M, Ikeda H, et al. Evaluation of Quantitative Portal Venous, Hepatic Arterial and Total Hepatic Tissue Blood Flow Using Xenon CT in Alcoholic Liver Cirrhosis- Comparison with Liver Cirrhosis C. Alcohol Clin Exp Res 2007; 31:S43-S48.

Kobayashi M, Suzuki M, Ikeda H, et al. Assessment of hepatic steatosis and hepatic tissue blood flow by xenon computed tomography in nonalcoholic steatohepatitis. Hepatol Res 2009; 39(1): 31-39.

Takahashi H, Suzuki M, Ikeda H, et al. Evaluation of Quantitative Portal Venous, Hepatic Arterial, and Total Hepatic Tissue Blood Flow Using Xenon CT in Alcoholic Liver Cirrhosis- Comparison With Liver Cirrhosis Related to Hepatitis C Virus and Nonalcoholic Steatohepatitis. Alcohol Clin Exp Res 2010; 34: S7-13.

Sase S, Takahashi H, Ikeda H, et al. Determination of time-course change rate for arterial xenon using the time course of tissue xenon concentration in xenon-enhanced computed tomography. Med Phys 2008; 35:2331-2338.

Ryuta Shigefuku, Hideaki Takahashi, Minoru Kobayashi, et al. Pathophysiological analysis of nonalcoholic fatty liver disease by evaluation of fatty liver changes and blood flow using xenon computed tomography: can early-stage nonalcoholic steatohepatitis be distinguished from simple steatosis?  J Gastroenterol. 2012 E-pub.
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
2001 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2001 Year 10 Month 01 Day
Last follow-up date
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
2016 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009510

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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