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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027682
Receipt No. R000031695
Scientific Title Effectiveness of preoperative nutrition and rehabilitation therapy for sarcopenia in patients undergoing hepatobiliary and pancreatic surgery
Date of disclosure of the study information 2017/06/09
Last modified on 2017/12/12

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Basic information
Public title Effectiveness of preoperative nutrition and rehabilitation therapy for sarcopenia in patients undergoing hepatobiliary and pancreatic surgery
Acronym Effectiveness of preoperative nutrition and rehabilitation for sarcopenia
Scientific Title Effectiveness of preoperative nutrition and rehabilitation therapy for sarcopenia in patients undergoing hepatobiliary and pancreatic surgery
Scientific Title:Acronym Effectiveness of preoperative nutrition and rehabilitation for sarcopenia
Region
Japan

Condition
Condition HCC,biliary cancer, pancreatic cancer, metastatic liver cancer, benign disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of preoperative nutrition and prehabilitation therapy for sarcopenia on hepatectomy and pancreatectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skeletal muscle mass
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Nutrition
Branched-chain amino acid supplementation
Aminoleban EN powder mix
Livact

The patients in the BCAA supplementation groups took one sachet of Aminoleban and/or Livact three times daily after meals.

Enteral nutrition product
Ensure Liquid
Interventions/Control_2 Rehabilitation
Resistance exercises
Theraband resistance training
Inspiratory muscle strengthening
Aerobic exercises
Walking
Treadmill
Ergometer
Ascending/descending stairs
Interventions/Control_3 Nutrition and rehabilitation
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 1) The patient with a malignant tumor (hepatocellular carcinoma, metastatic liver cancer, biliary cancer, pancreatic cancer) or benign hepatobiliary and pancreatic disease.
2) Hepatectomy or pancreatectomy planted patient.
3) 20 years or older.
4) Agreement is provided in a document about the participation of this study.



The patients who underwent hepatectomy or pancreatectomy.


he primary diseases were categorized as benign disease (n = 6; 7%), HCC (n = 21; 26%), biliary cancer (n = 9; 11%), pancreatic cancer (n = 13; 16%), metastatic liver cancer 27 (33%), and others (n = 6; 7%).
Key exclusion criteria 1) The patient who have active diseases other than resection planned tumor
2) The patient who cannot walk
3) The patient who cannot eat
4) The patient who was judged to be inappropriate
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichiro Araki
Organization Integrative Center of General Surgery, Gunma University Hospital
Division name Hepatobiliary and Pancreatic Surgery
Zip code
Address 3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
TEL 027-220-8229
Email karaki@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Tsukagoshi
Organization Integrative Center of General Surgery, Gunma University Hospital
Division name Hepatobiliary and Pancreatic Surgery
Zip code
Address 3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
TEL 027-220-8229
Homepage URL
Email m13702038@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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
2017 Year 06 Month 09 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 08 Day
Last modified on
2017 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031695

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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