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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024079
Receipt No. R000027720
Scientific Title The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/16

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Basic information
Public title The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Acronym The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein
Scientific Title The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein for pancreatic cancer
Scientific Title:Acronym The study of left-sided portal hypertention after pancreaticoduodenectomy with combined resection of portal vein
Region
Japan

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

Objectives
Narrative objectives1 To identify the incidence and impact of left-sided portal hypertention after PD for pancreatic cancer, which have yet to be elucidated.
Basic objectives2 Others
Basic objectives -Others Even in the high volume centers, the method to prevent the left-sided portal hypertention is still not standardized. Therefore, we evaluate the best procedure for its prevention using multi-center questionaries.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of left-sided portal hypertention according to the various procedures.
To identify it, we evaluate the incidence of gastrointestinal bleedings from the varices, platelets counts and spleen volume on POD 6 and 12 months
Key secondary outcomes Analysis if various risk factors causing the left-sided portal hypertention after pancreaticduodenectomy

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Cases in which PD with PV resection were conducted.
2) Patients whose CT scan and Lab data were available on POM 6 and 12.
Key exclusion criteria The patients of whom the criteria above mentioned were not satisfied.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Isaji
Organization Mie university
Division name Hepatobiliary pancreatic and transplant surgery
Zip code
Address 2-174 Edobashi Tsu Mie, Japan ZIP:514-8507
TEL 0592321111
Email isaji-s@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shugo Mizuno
Organization Mie university
Division name Hepatobiliary pancreatic and transplant surgery
Zip code
Address 2-174 Edobashi Tsu Mie, Japan ZIP:514-8507
TEL 0592321111
Homepage URL
Email mizunos@clin.medic.mie-u.ac.jp

Sponsor
Institute Hepatobiliary pancreatic and transplant surgery, Mie university
Institute
Department

Funding Source
Organization Japanese society of hepatobiliary pancreatic surgery
Organization
Division
Category of Funding Organization Other
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
2016 Year 10 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
2016 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We distributed the the first questionaries to the A ranked hospitals authorized by the Japanese society of hepatobiliary pancreatic surgery and selected the institutions in which PD with PV resection were carried out at least 10 cases from 2005.1 to 2014.12.

Management information
Registered date
2016 Year 09 Month 16 Day
Last modified on
2016 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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