UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accuracy of subcutaneous continuous glucose monitor during perioperative period
Title of the study (Brief title)	Accuracy of subcutaneous continuous glucose monitor
Region	Japan

Condition
Condition	Hepatocellular carcinoma, Pancreas tumor, Esophageal cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Aim of this study is examined the accuracy of a subcutaneous continuous glucose monitor during perioperative period.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference between glucose measured by subcutaneous continuous glucose monitor and glucose measured by artificial pancreas.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

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	Device,equipment
Interventions/Control_1	Subcutaneous continuous glucose monitor
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Schedule operated patient of liver, pancreas and esophagus
Key exclusion criteria	Patients who was not used an artificial pancreas for perioperative glucose control
Target sample size	15

Research contact person
Name of lead principal investigator	Kazuhiro Hanazaki
Organization	Kochi Medical School
Division name	Surgery
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL	088-880-2370
Email	hanazaki@kochi-u.ac.jp

Public contact
Name of contact person	Tomoaki Yatabe
Organization	Kochi Medical School
Division name	Anesthesiology
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL	088-880-2471
Homepage URL
Email	yatabe@kochi-u.ac.jp

Sponsor
Institute	Department of Surgery, Kochi Medical School
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Surgery, Kochi Medical School
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

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 28 Day
Anticipated trial start date	2014 Year 03 Month 08 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	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26721825
Results
Other related information

Management information
Registered date	2014 Year 03 Month 05 Day
Last modified on	2016 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000015568