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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027096
Receipt No. R000031039
Scientific Title Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Date of disclosure of the study information 2017/04/21
Last modified on 2017/04/21

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Basic information
Public title Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Acronym Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Scientific Title Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Scientific Title:Acronym Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Region
Japan

Condition
Condition end stage liver disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There has been no reports which described the use experience of Tolvaptan for the end stage of liver disease waiting for liver transplantation. This study is to elucidate efficacy and safety of using tolvaptan for the end stage liver disease complicated by refractory ascites.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of body weight after initiation
Key secondary outcomes urine volume,total-bilirubin,creatinine,sodium,Child-Pugh score,MELD score,Clavien-Dindo score,post operative day,readmission

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
70 years-old >
Gender Male and Female
Key inclusion criteria patients in end stage liver disease who was complicated by refractory ascites and was adaptive for liver transplantation
Key exclusion criteria 1.poor oral intake
2.past history to administrate tolvaptan
3.rejection by patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kaneko
Organization The University of Tokyo
Division name Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 0338155411
Email sho.kiritani@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Sho Kiritani
Organization The University of Tokyo
Division name Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 0338155411
Homepage URL
Email sho.kiritani@gmail.com

Sponsor
Institute The University of Tokyo
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2017 Year 04 Month 21 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 Main results already published
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 finished the observation of 10 patients and now analyzing the data

Management information
Registered date
2017 Year 04 Month 21 Day
Last modified on
2017 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031039

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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