UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research for efficacy of home enteral nutrition in patients with pancreaticoduodenectomy
Title of the study (Brief title)	Efficacy of home enteral nutrition in patients with pancreaticoduodenectomy
Region	Japan

Condition
Condition	Patients who had low oral intake after pancreaticoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is to evaluate the efficacy for home enteral nutrition in malnutritional patient after pancreaticoduodenectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratio of morbidity over Clavien-Dindo II between discharge and postoperative day 90.
Key secondary outcomes	Changes in Cholinesterase, Transthyretin, Albumin, lymphocytes, body weight and body component assessed with inbody.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	All patients who underwent PD were preoperatively evaluated for nutritional status with the use of blood tests and body component analyses (Inbody530; Inbody institute. Inc., Tokyo., Japan). the patient started oral fluid intake from postoperative day 1 and we administered enteral nutrition with rakol and twinrain. The volume of enteral nutrition was increasing gradually along with ideal body weight.Before discharge, we administered HEN in patients with maunutrition defined as oral intake below 15 kcal /iBW.HEN was introduced as 400-800 kcal/day to fulfill daily nutritional requirements and included any standard polymeric formula providing 1.0-1.5 kcal/ml with 50-60% carbohydrates, 25-35% lipids, and 12-20% protein. HEN could be withdrawn after 6 weeks from discharge if the oral diet was regular and adequate. After discharge, all patients were assessed regarding nutritional status and postoperative morbidity once every 2 weeks at outpatient clinics until 6 weeks after discharge. After that, they were assessed once per month until 3 months after discharge.
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	First include criterria was as follow. 1) the patients who undergo pancreatico duodenectomy 2) the patients over 20 years 3) the patients who fully consented this study Second inclusion criteria was as follow 1) the patients who had oral intake below 15 kcal/ideal body weight.
Key exclusion criteria	This study exclude this patients as follow;the patients who had ileus, unsufficient bowel, liver, or kidney function, severe diabetes mellitus, the difficulty in auqruiring home enteral nutrition.
Target sample size	80

Research contact person
Name of lead principal investigator	Norihiro Kokudo
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepato-Pancreatico-Biliary Surgery Division, Department of Surgery
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8841
Email	kokudo-2su@h.u-tokyo.ac.jp

Public contact
Name of contact person	Daisuke Ito
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepato-Pancreatico-Biliary Surgery Division, Department of Surgery
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8841
Homepage URL
Email	itoudaisuke5995@yahoo.co.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 07 Day
Last modified on	2017 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029429