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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025572
Receipt No. R000029429
Scientific Title Exploratory research for efficacy of home enteral nutrition in patients with pancreaticoduodenectomy
Date of disclosure of the study information 2017/02/01
Last modified on 2017/01/07

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Basic information
Public title Exploratory research for efficacy of home enteral nutrition in patients with pancreaticoduodenectomy
Acronym Efficacy of home enteral nutrition in patients with pancreaticoduodenectomy
Scientific Title Exploratory research for efficacy of home enteral nutrition in patients with pancreaticoduodenectomy
Scientific Title:Acronym 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
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Pancreatico-Biliary Surgery Division, Department of Surgery
Zip code
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
1st name
Middle name
Last name Daisuke Ito
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Pancreatico-Biliary Surgery Division, Department of Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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