UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038652 |
|---|---|
| Receipt number | R000044041 |
| Scientific Title | The Safety and Feasibility of 30 min Intermittent Pringle Maneuver during Liver Resection: A Prospective Single-Center Phase II Trial |
| Date of disclosure of the study information | 2019/11/21 |
| Last modified on | 2019/11/21 11:36:50 |
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Basic information
Public title
The Safety and Feasibility of 30 min Intermittent Pringle Maneuver during Liver Resection: A Prospective Single-Center Phase II Trial
Acronym
PLIVER30
Scientific Title
The Safety and Feasibility of 30 min Intermittent Pringle Maneuver during Liver Resection: A Prospective Single-Center Phase II Trial
Scientific Title:Acronym
PLIVER30
Region
| Japan |
Condition
Condition
Liver disease requiring hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and feasibility of 30 min intermittent pringle maneuver during liver resection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative liver function
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
30 min Intermittent Pringle Maneuver during Liver Resection
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
liver disease requiring hepatectomy
Patients scheduled to have intermittent pringle maneuver during liver resection
18 years old or older
Patients who have written consent to participate in this study
Key exclusion criteria
Patients with preoperative liver dysfunction (Child C or ICGR15 25% or more)
Repeat hepatectomy
Biliary reconstruction
Other organs resection (excluding cholecystectomy)
Use antiplatelet / anticoagulant just before surgery
High risk of intraoperative bleeding due to a wide hepatic section and other reasons
Pregnant
ECOG performance status 3 or higher
Other cases judged by the attending physician to be inappropriate for registration
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Fukami |
| Middle name | |
| Last name | Yasuyuki |
Organization
Aichi Medical University
Division name
Department of Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
yasuyuki490225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Fukami |
| Middle name | |
| Last name | Yasuyuki |
Organization
Aichi Medical University
Division name
Department of Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
yasuyuki490225@yahoo.co.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi 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
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
0561-62-3311
amu_ethics@aichi-med-u.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
| 2019 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2019 | Year | 11 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044041
