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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028569
Receipt No. R000032699
Scientific Title Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study
Date of disclosure of the study information 2017/08/09
Last modified on 2017/08/08

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Basic information
Public title Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study
Acronym EUS evaluation of vascular invasion in pancreatic cancer
Scientific Title Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study
Scientific Title:Acronym EUS evaluation of vascular invasion in pancreatic cancer
Region
Japan

Condition
Condition Pancreatic ductal adenocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to analyses EUS signs of peripancreatic arterial and venous invasion in pancreatic carcinoma.
Since EUS tends to cause a difference in diagnostic accuracy by the operator, so in order to unify expressions between operators, we evaluated with the check sheet.And we examine correlation of EUS findings and postoperative pathology.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of preoperative EUS evaluation of PDAC vascular invasion and postoperative pathological results
Key secondary outcomes A) Ability to visualize various major blood vessels by EUS
B) Accuracy of staging in UICC TNM classification by EUS
C) Comparison of prognosis by presence or absence of vascular invasion in resected arteries

Base
Study type Observational

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) Pancreatic cancer patients who will under go surgery in our hospital.
2) Documented examination consent was obtained.
3) Age 20 years and over
4) After receiving sufficient explanation for the participation of this study, patients who obtained written agreement by the patient's free will with sufficient understanding
Key exclusion criteria 1) Patients diagnosed with distant metastasis before EUS
2) Patients with ECOG Performance status of 2 or more
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rintaro Mikata
Organization Chiba university hospital
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo, Chiba
TEL 043-222-7171
Email mikata@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mutsumi Yamato
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo, Chiba
TEL 043-222-7171
Homepage URL
Email aena2827@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization None
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
2017 Year 08 Month 09 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
2017 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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 We are planning to evaluate whether preoperative EUS evaluation of vascular invasion of pancreatic cancer is related with pathological result.

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032699

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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