UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020602
Receipt number R000023781
Scientific Title Protective efficacy of ornithine for the pancreatic fistula after pancreatectomy
Date of disclosure of the study information 2016/01/18
Last modified on 2019/07/22 16:40:34

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Basic information

Public title

Protective efficacy of ornithine for the pancreatic fistula after pancreatectomy

Acronym

Protective efficacy of ornithine for the pancreatic fistula after pancreatectomy

Scientific Title

Protective efficacy of ornithine for the pancreatic fistula after pancreatectomy

Scientific Title:Acronym

Protective efficacy of ornithine for the pancreatic fistula after pancreatectomy

Region

Japan


Condition

Condition

Patients with pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of ornithine for decreasing the pancreatic fistula after pancreatectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Development and severity of pancreatic fistula (between 3 and 14 days after surgery)

Key secondary outcomes

Postoperative complications without pancreatic fistula and development of surgical site infection


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of ornithine 2.4g from 7days ago until 14days later of the surgery

Interventions/Control_2

Control group: Patients without ingestion of ornithine

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

[Ornithine intake group]
20years or older
Patients who are possible to intake ornithine
[Control group]
Patients who were undergone pancreatectomy within 3years.

Key exclusion criteria

[Ornithine intake group]
Less than 20 years old
Patients who cannot understand study contents enough.
Consent is not obtained from the patients.
Patients who cannot take ornithine.
Patients who were not undergone pancreatectomy for any reason.
[Control group]
Consent is not obtained from the patients.

Target sample size

280


Research contact person

Name of lead principal investigator

1st name Yutaka
Middle name
Last name Yutaka

Organization

Kyorin University, School of medicine

Division name

Department of Surgery

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

+81-422-47-5511

Email

ysuzuki@ks.kyorin-u.ac.jp


Public contact

Name of contact person

1st name Yutaka
Middle name
Last name Yutaka

Organization

Kyorin University, School of medicine

Division name

Department of Surgery

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

+81-422-47-5511

Homepage URL


Email

ysuzuki@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University, School of Medicine

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

Institutional Review Board of Kyorin University

Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

Tel

+81-422-47-5511

Email

irb@ks.kyorin-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

2016 Year 01 Month 18 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

Terminated

Date of protocol fixation

2015 Year 12 Month 28 Day

Date of IRB

2015 Year 12 Month 28 Day

Anticipated trial start date

2016 Year 01 Month 18 Day

Last follow-up date

2018 Year 03 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

2016 Year 01 Month 17 Day

Last modified on

2019 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023781


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name