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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||||
Condition | Chronic liver disease with hypersplenism | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | |||||||
Public contact | |||||||
Name of contact person |
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Organization | Osaka Medical Center for Cardiovascular Disease and Cancer | ||||||
Division name | Department of hepatobiliary and pancreatic oncology | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |