UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004975 |
|---|---|
| Receipt number | 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 | 2021/03/18 09:56:44 |
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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
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
kenya.y@hx5.ecs.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 18 | Day |
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
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005878
