UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of perioperative blood glucose management using artificial pancreas in patients with hepato-pancreato-biliary surgery
Title of the study (Brief title)	The efficacy and safety of perioperative blood glucose management using artificial pancreas
Region	Japan

Condition
Condition	Hepatectomy above 1 sector Pancreatoduodenectomy Distal pancreatectomy
Classification by specialty	Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety (hypoglycemic attack) and efficacy (postoperative complications and hospital days)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of postoperative complications
Key secondary outcomes	1) Perioperative blood glucose values, glycemic variability 2) Postoperative hospital days 3) inflammation-related factors

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Treatment Group (Target blood glucose range is from 80 to 110 mg/dl)
Interventions/Control_2	Control Group (Target blood glucose range is from 80 to 180 mg/dl)
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients received following surgery a) Hepatectomy above 1 sector b) Pancreatoduodenectomy c) Distal pancreatectomy 2) ECOG Performance Status Scale: 0-1 3) Patients with impaired glucose tolerance 4) Age between 20 y.o. to 85 y.o.
Key exclusion criteria	1)Patients with severe respiratory disease 2)Dialysis patients with chronic renal failure 3)Other inadequate case judged by study participated doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroya Akabori
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2238
Email	hakabori@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hiroya Akabori
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2238
Homepage URL
Email	hakabori@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	NIKKISO CO,.LTD
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 08 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 10 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 09 Month 01 Day
Date analysis concluded	2018 Year 09 Month 30 Day

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

Management information
Registered date	2016 Year 08 Month 03 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027033