UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Title of the study (Brief title)	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	Junichi Kaneko
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0338155411
Email	sho.kiritani@gmail.com

Public contact
Name of contact person	Sho Kiritani
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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