UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic ultrasonography in evaluation of vascular invasion in preoperative pancreatic cancer; prospective study
Title of the study (Brief title)	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	Rintaro Mikata
Organization	Chiba university hospital
Division name	Gastroenterology
Address	1-8-1 Inohana, Chuo, Chiba
TEL	043-222-7171
Email	mikata@faculty.chiba-u.jp

Public contact
Name of contact person	Mutsumi Yamato
Organization	Chiba University Hospital
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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