UMIN-CTR Clinical Trial

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 Kenichiro Middle name Last name Araki
Organization	Integrative Center of General Surgery, Gunma University Hospital
Division name	Hepatobiliary and Pancreatic Surgery
Zip code	371-8511
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 Mariko Middle name Last name Tsukagoshi
Organization	Integrative Center of General Surgery, Gunma University Hospital
Division name	Hepatobiliary and Pancreatic Surgery
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
TEL	027-220-8229
Homepage URL
Email	marikot@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	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi Gunma 371-8511, Japan
Tel	026-220-8740
Email	r_taguchi@gunma-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	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	2016 Year 09 Month 29 Day
Anticipated trial start date	2017 Year 06 Month 09 Day
Last follow-up date	2021 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	2017 Year 06 Month 08 Day
Last modified on	2021 Year 01 Month 10 Day

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