UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051266 |
|---|---|
| Receipt number | R000058465 |
| Scientific Title | Effect of early administration of tolvaptan on pleural effusion post-hepatectomy |
| Date of disclosure of the study information | 2023/06/05 |
| Last modified on | 2023/06/05 18:12:40 |
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Basic information
Public title
Effect of early administration of tolvaptan on pleural effusion post-hepatectomy
Acronym
Effect of early administration of tolvaptan on pleural effusion post-hepatectomy
Scientific Title
Effect of early administration of tolvaptan on pleural effusion post-hepatectomy
Scientific Title:Acronym
Effect of early administration of tolvaptan on pleural effusion post-hepatectomy
Region
| Japan |
Condition
Condition
Cases of hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical effect of early postoperative administration of tolvaptan on pleural effusion after hepatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pleural effusion volume on post-hepatectomy day 5
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were administered 7.5 mg of tolvaptan with 25 mg of spironolactone per day from the post-hepatectomy day 1 to 5.
Interventions/Control_2
Usual postoperative management
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
Consecutive cases of hepatectomy performed between January 2019 and February 2021 (26 months).(Over 20 years old)
Key exclusion criteria
Patients with hyperkalemia (>5.5 mEq/L), diabetes insipidus, preoperative blood sodium level of <125 mEq/L or >150 mEq/L, serum creatinine level of >2 mg/dL, difficulties in communication due to psychiatric disorders, patients on dialysis, and those on tolvaptan orally administered before hepatectomy.
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Iida |
Organization
Shiga Medical University
Division name
Surgery
Zip code
520-2192
Address
Seta-Tsukinowa cho, Otsu, Shiga
TEL
077-548-2238
hiroya@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Iida |
Organization
Shiga Medical University
Division name
Surgery
Zip code
520-2192
Address
Seta-Tsukinowa cho, Otsu, Shiga
TEL
077-548-2238
Homepage URL
hiroya@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga Medical University
Institute
Department
Personal name
Funding Source
Organization
Shiga Medical 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
Shiga Medical University
Address
Seta-Tsukinowa cho, Otsu, Shiga
Tel
077-548-2238
hiroya@belle.shiga-med.ac.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
| 2023 | Year | 06 | Month | 05 | 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
136
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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058465
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
