UMIN-CTR Clinical Trial

Basic information
Public title	Study of perioperative nutritional status improved by immunoenhancing enteral nutrients in patients who underwent pancreaticoduodenectomy.
Acronym	Nutritional intervention trials in patients who underwent pancreaticoduodenectomy.
Scientific Title	Study of perioperative nutritional status improved by immunoenhancing enteral nutrients in patients who underwent pancreaticoduodenectomy.
Scientific Title:Acronym	Nutritional intervention trials in patients who underwent pancreaticoduodenectomy.
Region	Japan

Condition
Condition	Pancreatic cancer, Bile duct cancer, Duodenal cancer, Intraductal papillary mucinous neoplasm, Neuroendocrine tumor, Mesenchymal tumor
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the improvement of nutritional status and reduction of postoperative infectious complications by ingestion of immunoenhancing enteral nutrients in patients undergoing pancreaticoduodenectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body cell mass
Key secondary outcomes	Infectious complications, Other complications, Nutritional indexes, Length of hospital stay, Recurrence-free survival time, Overall survival

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	Food
Interventions/Control_1	Intake of immune-enhancing enteral nutrients from 2 weeks before surgery to 12 weeks after surgery. The dose of nutrients is approximately 600kcal per day.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients over the age of 20, and under the age of 80 2)Patients who will undergo Pancreaticoduodenectomy 3)Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
Key exclusion criteria	1)Patients who have active infection 2)Patients with milk allergy 3)Patients with ileus 4)Patients whose intestinal function is not the residual 5)Patients with advanced liver dysfunction or advanced renal dysfunction 6)Patients with abnormal glucose metabolism, such as severe diabetes 7)Patients with congenital disorders of amino acid metabolism 8)Patients who were deemed inappropriate for medical reasons
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kiyoshi Middle name Last name Hasegawa
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code	1138655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0358143933
Email	ichida-tky@umin.ac.jp

Public contact
Name of contact person	1st name Akihiko Middle name Last name Ichida
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code	1138655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	ichida-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo, Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
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	Clinical research support center, the university of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5800-8743
Email	p1unit-office@umin.net

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	2012 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	80
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	Completed
Date of protocol fixation	2012 Year 02 Month 20 Day
Date of IRB	2012 Year 04 Month 26 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2019 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	2012 Year 07 Month 04 Day
Last modified on	2019 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009615