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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004975
Receipt No. R000005878
Scientific Title A safety study of perioperative olprinone administration for liver resection
Date of disclosure of the study information 2011/05/01
Last modified on 2011/05/23

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Basic information
Public title A safety study of perioperative olprinone administration for liver resection
Acronym A safety study of olprinone for liver resection
Scientific Title A safety study of perioperative olprinone administration for liver resection
Scientific Title:Acronym A safety study of olprinone for liver resection
Region
Japan

Condition
Condition Primary liver cancer
Metastatic liver cancer
Classification by specialty
Hepato-biliary-pancreatic surgery Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the safety of perioperative olprinone administration and its protective effects against postoperative dysfunction after liver resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes Protective effects on the liver

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Perioperative olprinone administration
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Primary or metastatic liver cancer confirmed by clinical or histopathological examinations
2) Resectable liver cancer
3) Child Pugh classification A or B
4) Performance status 0-1
5) Adequate organ function
6) Ability of self-determination
7) Written informed consent
Key exclusion criteria 1) Biliary reconstruction
2) Gastrointestinal resection and lymphatic dissection
3) Preoperative percutaneous transhepatic portal embolization
4) Active double cancer
5) Serious complications such as heart or renal failure
6) A history of severe hypersensitivity
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuro Hatano
Organization Kyoto University Hospital
Division name Department of Surgery
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3242
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenya Yamanaka
Organization Kyoto University Hospital
Division name Department of Surgery
Zip code
Address
TEL 075-751-3242
Homepage URL
Email kenya.y@hx5.ecs.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Department of Surgery, Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 05 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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 28 Day
Last modified on
2011 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005878

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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