UMIN-CTR Clinical Trial

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

Patients who had low oral intake after pancreaticoduodenectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 HEN could be withdrawn after 6 weeks from discharge if the oral diet was regular and adequate.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

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

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

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

Institute

University of Tokyo

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

01

Month

07

Day

Last modified on

2017

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029429