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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016451
Receipt No. R000019108
Scientific Title Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery
Date of disclosure of the study information 2015/02/09
Last modified on 2018/03/20

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Basic information
Public title Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery
Acronym Clinical trial about safeness of perioperative blood glucose management using artificial pancreas in hepato-pancreato-biliary surgery
Scientific Title Confirmatory clinical trial about safeness of perioperative blood glucose management using artificial pancreas in division of hepato-pancreato-biliary surgery
Scientific Title:Acronym Clinical trial about safeness of perioperative blood glucose management using artificial pancreas in hepato-pancreato-biliary surgery
Region
Japan

Condition
Condition 1) Hepatectomy above 2 sectors
2) Pansreatoduodenectomy
3) Liver transplantation
Classification by specialty
Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm safeness of erioperative blood glucose management using artificial pancreas after hepato-pancreato-biliary surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of hypoglycemia under 60mg/dL
Key secondary outcomes 1) Incidence of postoperative infectious complications during hospitalization
2) Stability of blood glucose level (target level: 80~110mg/dL)
3) Compalison of blood glucose accuracy between artificial pancreas and conventional method

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Blood glucose management using artificial pancreas (24 hours)
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients received high invasive surgery.
a) Hepatectomy above 2 sectors
b) Pancreatoduodenectomy
c) Liver transplantation
2) ECOG Performance Status Scale: 0~2.
3) Without active infection before surgery.
4) Age between 20y.o. to 80y.o.
5) Clean to clean-contaminated wound.
Key exclusion criteria 1) Case of other organ excision.
2) Case of pregnant, breast-feeding and possible pregnant woman.
3) ASA score over 4.
4) Other inadequate case judged by study participated doctor.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takamura
Organization Kanazawa University Hospital
Division name Department of Hepato-Pancreato-Biliary and Transplant Surgery
Zip code
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2362
Email takamuh@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Hayashi
Organization Kanazawa University Hospital
Division name Department of Hepato-Pancreato-Biliary and Transplant Surgery
Zip code
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2362
Homepage URL
Email pwrofdrms2000@staff.kanazawa-u.ac.jp

Sponsor
Institute Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department

Funding Source
Organization Department of Gastroenterologic Surgery, Division of Cancer Medicine, Graduate School of Medical Science, Kanazawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 金沢大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 03 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 05 Day
Last modified on
2018 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019108

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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