UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041684
Receipt number R000047582
Scientific Title Efficacy and safety of tolvaptan for better management of patients undergoing liver resection, prospective study
Date of disclosure of the study information 2021/01/01
Last modified on 2022/04/05 10:28:48

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Basic information

Public title

Efficacy and safety of tolvaptan for better management of patients undergoing liver resection, prospective study

Acronym

Efficacy and safety of tolvaptan for liver resection, prospective study

Scientific Title

Efficacy and safety of tolvaptan for better management of patients undergoing liver resection, prospective study

Scientific Title:Acronym

Efficacy and safety of tolvaptan for liver resection, prospective study

Region

Japan


Condition

Condition

primary liver cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study investigates the efficacy and safety of tolvaptan use for the patients with liver cirrhosis after liver resection.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

trend of body weight after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

Tolvaptan use after liver resection for 1 week, as diuretics for postoperative edema from cirrhosis.

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

The patients preoperatively diagnosed with liver cirrhosis, who is scheduled to undergo liver resection for liver cancer.

Key exclusion criteria

The patients who rejected participation agreement

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masaji
Middle name
Last name Hashimoto

Organization

Toranomon hospital

Division name

Hepato-biliary pancreas surgery division,Department of Gastroenterological Surgery

Zip code

105-8470

Address

toranomon2-2-2, minatoku, tokyo

TEL

0335881111

Email

masaji.hashimoto@umin.ac.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name kobayashi

Organization

Toranomon hospital

Division name

Hepato-biliary pancreas surgery division,Department of Gastroenterological Surgery

Zip code

105-8470

Address

toranomon2-2-2, minatoku, tokyo

TEL

0335881111

Homepage URL


Email

yuutakobayashi-ncd@umin.ac.jp


Sponsor or person

Institute

Toranomon hospital

Institute

Department

Personal name



Funding Source

Organization

Okinaka memorial institute for medical disease

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of clinical research, toranomon hospital

Address

toranomon2-2-2, minatoku, tokyo

Tel

0335881111

Email

chiken-jim@toranomon.gr.jp


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

2021 Year 01 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

2020 Year 09 Month 23 Day

Date of IRB

2019 Year 06 Month 03 Day

Anticipated trial start date

2020 Year 11 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 04 Day

Last modified on

2022 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name