UMIN-CTR Clinical Trial

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
Institute	Osaka Medical Center for Cardiovascular Disease and Cancer
Institute
Department

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
URL(English)	https://upload.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

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