UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004269
Receipt number R000004316
Scientific Title Clinical trial for improving liver function
Date of disclosure of the study information 2010/10/01
Last modified on 2015/09/28 15:19:54

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Basic information

Public title

Clinical trial for improving liver function

Acronym

ILF trial

Scientific Title

Clinical trial for improving liver function

Scientific Title:Acronym

ILF trial

Region

Japan


Condition

Condition

Chronic liver disease with hypersplenism

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effects of splenectomy or splenic irradiation on symptom of hypersplenism and liver function in patients with chronic liver disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Symptom of hypersplenism
Liver functional reserve

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver Other

Interventions/Control_1

Splenectomy

Interventions/Control_2

Irradiation of spleen

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Chronic liver disease
Thrombocytopenia (=< 100 / mL) which makes patients difficult to be treated with interferon or anti-HCC Therapy.
PS = 0 or 1
Life expectancy of at least 6 months
Written informed consent was obtained

Key exclusion criteria

Presence of esophageal or gastric varix at risk of bleeding within 6 months
Patients with HCC who need to be treated within 6 months
Pregnant or nursing patients
Presence of lung fibrosis
Patients who associated with heavy cardiac or renal disease
Patients diagnosed to be inappropriate by an attending doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Katayama

Organization

Osaka Medical Center for Cardiovascular Disease and Cancer

Division name

Department of hepatobiliary and pancreatic oncology

Zip code


Address

Nakamichi 1-3-3, Higashinari-ku, Osaka, Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka Medical Center for Cardiovascular Disease and Cancer

Division name

Department of hepatobiliary and pancreatic oncology

Zip code


Address


TEL


Homepage URL


Email

katayama-ka@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cardiovascular Disease and Cancer

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for Cardiovascular Disease and Cancer
Osaka Seijinbyo Yoboukyoukai

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


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



Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 01 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

Terminated

Date of protocol fixation

2010 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2012 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 27 Day

Last modified on

2015 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004316


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name