UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	EUS-FNA for pancreato-biliary cancers as preoperative study method to evaluate paraaortic lymph node metastasis.
Title of the study (Brief title)	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	Tsutomu Chiba
Organization	Kyoto University
Division name	Department of gastroenterology ahd hepatology
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	Akira Kurita
Organization	Kyoto University
Division name	Department of gastroenterology ahd hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007603