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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004269
Receipt No. 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

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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
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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