UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The interventional trial for the test of utility of artificial pancreas on pancreas transplantation
Title of the study (Brief title)	Artificial pancreas on pancreas transplantation
Region	Japan

Condition
Condition	Type 1 diabetes, Chronic kidney disease
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The test of utility of artificial pancreas on pancreas transplantation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Glucose tolerance accessed by OGTT one month after transplantation
Key secondary outcomes	Blood flow velocity and resistance accessed by CEUS , morbidity, Days of ICU stay, Days of hospitalization

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	use artificial pancreas for the perioperative period of the pancreas transplant
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	The pancreas transplant that is enforced in our hospital which was able to get an agreement
Key exclusion criteria	subject is otherwise considered ineligible for the study by the investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Takashi Kenmochi
Organization	Fujita Health University Hospital
Division name	Department of Organ Transplant Surgery
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL	0562-93-9043
Email	kenmochi@fujita-hu.ac.jp

Public contact
Name of contact person	Taihei Ito
Organization	Fujita Health University Hospital
Division name	Department of Organ Transplant Surgery
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL	0562-93-2380
Homepage URL
Email	i-taihei@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University HospitalDepartment of Organ Transplant Surgery
Institute
Department

Funding Source
Organization	Ministry of Education
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	藤田保健衛生大学病院（愛知県）/Fujita Health University Hospital(Aichi)

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 29 Day
Anticipated trial start date	2017 Year 02 Month 02 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	2017 Year 04 Month 27 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031129