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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006408
Receipt No. R000007603
Scientific Title EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis.
Date of disclosure of the study information 2011/10/30
Last modified on 2016/08/25

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Basic information
Public title EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis.
Acronym EUS-FNA study for preoperative pancreato-biliary cancers
Scientific Title EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis.
Scientific Title:Acronym EUS-FNA study for preoperative pancreato-biliary cancers
Region
Japan

Condition
Condition pancreatic cancer, biliary tract cancer
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of EUS-FNA as preoperative method for paraaortic lymph node metastasis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Evaluate the efficacy of EUS-FNA for paraaortic lymph nodes.
Key secondary outcomes (1) comparison with FDG-PET, (2)complications, (3) quality of specimen material

Base
Study type Interventional

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 The number of patients until Des 2016.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Preoperative state of pancreatic cancer or bliary tract cancer,
(2) PS1 or 2
Key exclusion criteria (1) Patients who have allergy for contrast medium
(2) Patients with bleeding tendency
(3) Patients under anticoaglant therapy
(4) Plt< 30000
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Chiba
Organization Kyoto University
Division name Department of gastroenterology ahd hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4319
Email chiba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kurita
Organization Kyoto University
Division name Department of gastroenterology ahd hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4319
Homepage URL
Email akurita@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of gastroenterology ahd hepatology, Kyoto University
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
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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 26 Day
Last modified on
2016 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007603

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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