UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011904
Receipt No. R000013727
Scientific Title Study of changes in organ blood flow in Appleby operation for pancreatic body cancer
Date of disclosure of the study information 2013/09/30
Last modified on 2013/09/30

* 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 Study of changes in organ blood flow in Appleby operation for pancreatic body cancer
Acronym Study of changes in organ blood flow in Appleby operation for pancreatic body cancer
Scientific Title Study of changes in organ blood flow in Appleby operation for pancreatic body cancer
Scientific Title:Acronym Study of changes in organ blood flow in Appleby operation for pancreatic body cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the clinical significance of preserving the left gastric artery blood flow during the Appleby operation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Changes of the blood flow in the hepatic artery, left gastric artery and hepatic parenchyma by clamping the common hepatic artery.
Key secondary outcomes Dietary intake, weight loss

Base
Study type

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
Maneuver
Interventions/Control_1 Elective surgery cases of pancreatic cancer
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 ECOG performance status:0 to 2
who agree this study
Key exclusion criteria laparoscopic surgery
history of abdominal surgery
chronic heart failure
chronic renal failure
liver chirrosis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name j-yamamoto
Organization National Defense Medical College
Division name Surgery
Zip code
Address Namiki 3-2, Tokorozawa, Saitama, Japan
TEL +81-4-2995-1211
Email akifumi@muse.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Yamamoto
Organization National Defense Medical College
Division name Surgery
Zip code
Address Namiki 3-2, Tokorozawa, Saitama, Japan
TEL +81-4-2995-1211
Homepage URL
Email jyamamot@ndmc.ac.jp

Sponsor
Institute Department of Surgery, National defense Medical college
Institute
Department

Funding Source
Organization Defense medicine for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2013 Year 09 Month 30 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
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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
2013 Year 09 Month 30 Day
Last modified on
2013 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.