UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Acronym	Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Scientific Title	Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Scientific Title:Acronym	Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy
Region	Japan

Condition
Condition	Patients who undergo pancreatoduodenectomy for peri-pancreatic tumors such as pancreatic cancers or lower bile duct cancers
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study to compare prospectively the efficacy of K-2S plus as enteral nutrients after pancreatoduodenectomy to that of ELENTAL.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency Fecal condition (Bristol scale)
Key secondary outcomes	Weight loss rate Lymphocyte count and reduction rate Serum albumin level and reduction rate Serum prealbumin (transthyretin) levels and reduction rates Postoperative complication rate (Clavian-Dindo IIIa or more) Enteral nutrition protocol completion rate Enteral nutrition protocol total administered calories Total calories required after enteral feeding protocol

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Patients who will undergo PD will be prospectively registered and assigned to K-2S plus group from patients who have started registration. When the number of cases in the K-2S plus group reaches 20, the assignment to the K-2S plus group ends.
Interventions/Control_2	Cases in which IC of K-2S plus administration can not be obtained will be assigned to the Elental group. After the K-2S plus group reached 20 cases, all were assigned to the Elenthal group, and when the Elental group reached 20 cases, the entire assignment was completed.
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) Cases where the age of registration date is over 20 years old (2) PS (ECOG) 0 or 1 case (3) Cases that meet all the following conditions For all test items, the latest value is used within 14 days before surgery (a test on the same day two weeks before the registration date is acceptable). 1) White blood cells> or more 4,000 and < or less 12,000. 2) Neutrophil> or more 2,000. 3) Platelets> or more 100,000. 4) Hemoglobin> or more 8.0. 5) AST< or less 100. 6) ALT< or less 100. 7) Total bilirubin< or less 1.2. 8) Serum creatinine< or less 1.2. (4) Cases that can be taken orally (Dysphagia score< or less 1).
Key exclusion criteria	(1) Patients who are contraindicated with K-2S plus or Erental 1) A case with allergies to eggs, dairy products and soy 2) A case with hypersensitivity to K-2S plus 3) A case with hypersensitivity to Ellenthal 4) A case with amino acid metabolism disorder (2) Cases with active bacterial and fungal infections (cases with fever above 38 degree and cases where bacterial infection has been shown by imaging or bacteriological examination). (3) A case that is complicated by psychosis or psychiatric symptoms and difficult to participate in this study. (4) Cases that the study responsible (share) physician judged inappropriate for this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Baba
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Gastroenterological Surgery
Zip code	860-8556
Address	1-1-1, Honjo, Chuo-ku, Kumamoto
TEL	096-373-5211
Email	hdobaba@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Yo-ichi Middle name Last name Yamashita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Gastroenterological Surgery
Zip code	860-8556
Address	1-1-1, Honjo, Chuo-ku, Kumamoto
TEL	096-373-5211
Homepage URL
Email	y-yama@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
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	Kumamoto University Hospital
Address	1-1-1, Honjo, Chuo-ku, Kumamoto
Tel	096-373-5966
Email	byi-senshin@jimu.kumamoto-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	2019 Year 05 Month 07 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	2019 Year 04 Month 15 Day
Date of IRB	2019 Year 04 Month 22 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2021 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	2019 Year 04 Month 15 Day
Last modified on	2019 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041594