UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer
Title of the study (Brief title)	The research of HIFU therapy for unresectable pancreas cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to evaluate the safety in HIFU therapy for unresectable pancreatic cancer and establish HIFU therapeutic method for pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	the safety
Key secondary outcomes	the effect and usefulness of therapy

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	HIFU equipment:FEP-BY02(China Medical Tecnologies Co.)
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	* age >20 years old * WBC > 2000 Plt >5 Cre > 3.0 mg/dl *Normal EKG *PS: 0~3 *Survival time > 4 weeks
Key exclusion criteria	*The patients with other malignancy *Pregnancy case *Obstructive Jaundice *The patients with severe heart and brain disease
Target sample size	50

Research contact person
Name of lead principal investigator	Atsushi Sofuni
Organization	Tokyo Medical University
Division name	Gastroenterology and Hapatology
Address	6-7-1 Nishishinjuku Shinjuku-ku 160-0023 Tokyo Japan
TEL	03-3342-6111
Email	naika4@tokyo-med.ac.jp

Public contact
Name of contact person	Atsushi Sofuni
Organization	Tokyo Medical University
Division name	Gastroenterology and hepatology
Address	6-7-1 Nisishinjuku Shinjyuku-ku 160-0023
TEL	03-3342-6111
Homepage URL
Email	a-sofuni@amy.hi-ho.ne.jp

Sponsor
Institute	Tokyo Medical University Dept.of Gastroenterology and hepatology
Institute
Department

Funding Source
Organization	Cancer therapy research group of Tokyo Medical University
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	東京医科大学　消化器内科 Tokyo Medical University Dept. of Gastroenterology and hapatology

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 02 Month 05 Day
Anticipated trial start date	2013 Year 02 Month 05 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

Management information
Registered date	2013 Year 02 Month 05 Day
Last modified on	2017 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011664