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
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
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
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
