UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048073 |
|---|---|
| Receipt number | R000054788 |
| Scientific Title | A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Resection for Hepato-Pancreato-Biliary Surgeries. |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2022/06/16 15:06:47 |
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Basic information
Public title
A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Resection for Hepato-Pancreato-Biliary Surgeries.
Acronym
RENUH trial
Scientific Title
A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Resection for Hepato-Pancreato-Biliary Surgeries.
Scientific Title:Acronym
RENUH trial
Region
| Japan |
Condition
Condition
HBP malignancies (major hepatectomy, pancreatoduodenectomy)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Resection for Hepato-Pancreato-Biliary Surgeries.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the achievement rate of rehabilitation and nutritional intervention
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
preoperative rehabilitation and nutritional intervention
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 who are going to undergo major open hepatectomy or pancreatoduodenectomy
Key exclusion criteria
The patients who have uncontrollable infection, diabetes, cerebral infarction, and myocardial infarction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Kitago |
Organization
Keio University
Division name
Department of Surgery
Zip code
160-8582
Address
Shinjyukuku Shinanomachi 35
TEL
03-3353-1211
dragonpegasus@keio.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Uemura |
Organization
Keio University
Division name
Department of Surgery
Zip code
160-8582
Address
Shinjyukuku Shinanomachi 35
TEL
03-3353-1211
Homepage URL
ShoUemura0419@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University IRB
Address
Shijyukuku Shinanomachi 35
Tel
03-3353-1211
med-rinri-ft_pt@adst.keio.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
| 2022 | Year | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054788
| 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 |
