UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040975
Receipt number R000046747
Scientific Title A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy
Date of disclosure of the study information 2020/09/01
Last modified on 2021/02/04 14:35:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy

Acronym

A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy

Scientific Title

A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy

Scientific Title:Acronym

A prospective study to verify the effectiveness of postoperative nutrition therapy with amino acid preparation for patients after pancreatectomy

Region

Japan


Condition

Condition

after pancreaticoduodenectomy and total pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to verify whether postoperative nutrition therapy with amino acid preparation contributes to the improvement of nutritional status in patients after pancreatectomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Serum albumin level 30 days after surgery

Key secondary outcomes



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

Medicine

Interventions/Control_1

Administration of amino acid preparations for 7 days or more from the second day after surgery

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

1)Patients 20 years old or more
2)Patients who have undergone pancreaticoduodenectomy or total pancreatectomy

Key exclusion criteria

1)Contraindication to amino acid preparations
2)With active double cancer(Excluding early gastrointestinal cancer radically resected by endoscopic treatment)
3)Dialysis patient
4)Continuous systemic steroid therapy
5)Pregnant or possibility of pregnancy or breastfeeding
6)Patient registered to the other study whose endpoints are same to this study
7) Judged by the investigator to be inappropriate for this study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Hirochika
Middle name
Last name Toyama

Organization

Kobe University Hospital

Division name

Division of Hepato-Biliary-Pancreatic surgery

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo, Japan

TEL

078-382-6302

Email

toyama@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Ogura

Organization

Kobe University Hospital

Division name

Division of Hepato-Biliary-Pancreatic surgery

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo, Japan

TEL

078-382-6302

Homepage URL


Email

yutakobe@hotmail.co.jp


Sponsor or person

Institute

Division of Hepato-Biliary-Pancreatic surgery,Kobe University Hospital

Institute

Department

Personal name



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

Kobe University Hospital Clinical Translational Research Center

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo, Japan

Tel

078-382-6669

Email

kainyu@med.kobe-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

2020 Year 09 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

Open public recruiting

Date of protocol fixation

2020 Year 06 Month 29 Day

Date of IRB

2020 Year 09 Month 14 Day

Anticipated trial start date

2020 Year 09 Month 14 Day

Last follow-up date

2024 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

2020 Year 07 Month 02 Day

Last modified on

2021 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name