UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020602
Receipt No. 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

* 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 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
Institute Kyorin University, School of Medicine
Institute
Department

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
URL(English) https://upload.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


Contact us.