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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048073
Receipt No. 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

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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
Email 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
Email ShoUemura0419@gmail.com

Sponsor
Institute Keio University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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