UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy
Acronym	A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy
Scientific Title	A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy
Scientific Title:Acronym	A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy
Region	Japan

Condition
Condition	after pancreaticoduodenectomy and total pancreatectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to verify whether postoperative nutrition therapy with amino acid preparation contributes to the improvement of nutritional status in patients after pancreatectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum albumin level 30 days after surgery
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of amino acid preparations for 7 days or more from the second day after surgery
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	1)Patients 20 years old or more 2)Patients who have undergone pancreaticoduodenectomy or total pancreatectomy
Key exclusion criteria	1)Contraindication to amino acid preparations 2)With active double cancer(Excluding early gastrointestinal cancer radically resected by endoscopic treatment) 3)Dialysis patient 4)Continuous systemic steroid therapy 5)Pregnant or possibility of pregnancy or breastfeeding 6)Patient registered to the other study whose endpoints are same to this study 7) Judged by the investigator to be inappropriate for this study
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Hirochika Middle name Last name Toyama
Organization	Kobe University Hospital
Division name	Division of Hepato-Biliary-Pancreatic surgery
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo, Japan
TEL	078-382-6302
Email	toyama@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Yuta Middle name Last name Ogura
Organization	Kobe University Hospital
Division name	Division of Hepato-Biliary-Pancreatic surgery
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo, Japan
TEL	078-382-6302
Homepage URL
Email	yutakobe@hotmail.co.jp

Sponsor
Institute	Division of Hepato-Biliary-Pancreatic surgery,Kobe University Hospital
Institute
Department

Funding Source
Organization	None
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	Kobe University Hospital Clinical Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo, Japan
Tel	078-382-6669
Email	kainyu@med.kobe-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	2020 Year 09 Month 01 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	2020 Year 06 Month 29 Day
Date of IRB	2020 Year 09 Month 14 Day
Anticipated trial start date	2020 Year 09 Month 14 Day
Last follow-up date	2024 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	2020 Year 07 Month 02 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046747