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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name