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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028036
Receipt No. R000032066
Scientific Title Perioperative glycemic control using artificial pancreas for surgical diabetes
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/01

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Basic information
Public title Perioperative glycemic control using artificial pancreas for surgical diabetes
Acronym Perioperative glycemic control using artificial pancreas
Scientific Title Perioperative glycemic control using artificial pancreas for surgical diabetes
Scientific Title:Acronym Perioperative glycemic control using artificial pancreas
Region
Japan

Condition
Condition Patients without diabetes mellitus who were received surgical operation including esophagectomy, gastrectomy, hepatectomy and pancreatectomy
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate blood glucose ranging for patients without diabetes mellitus who undergo surgical operation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum IL-6 levels on on postoperative 3.
Key secondary outcomes CRP, Incidence of Systemic inflammatory response syndrome, Surgical Site Infection and morbidities.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Perioperative glycemic control using artificial pancreas is performed to be targeting blood glucose ranging from 80 to 110 mg/dL during 2 days.
Interventions/Control_2 Perioperative glycemic control using artificial pancreas is performed to be targeting blood glucose ranging from 110 to 140 mg/dL during 2 days.
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 who undergo esophagectomy, gastrectomy, hepatectomy and pancreatectomy.
2. Patients without diabetes mellitus whose Hemoglobine A1c is 6.4% or below.
3. A performance status of 0-2 accord
ing to the Eastern Cooperative Oncol
ogy Group (ECOG) scale.
4. An age of 20 years and over.
5. Patients who are considered to survive for more than 3 months from the registration.
6. Vital organ functions are preserved within 14 days prior to entry.
7. Sufficient oral intake.
8. All patients gave written informed
consent.
Key exclusion criteria 1. Obvious infection or inflammation.
2. Serious cardiovascular diseases.
3. Serious concurrent disease such as intestinal palsy, small bowel obstraction, uncontrolable diabetes mellitus, renal failure, liver cirrhosis, and so on.
4. Massive ascites beyond the pelvic cavity or pleural effusion.
5. Women who are pregnant or hope to become pregnant during the study period. Men who wish their partner to become pregnant.
6. Patients judged inappropriate for the study by their physicians.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL +81-88-880-2370
Email tsutomun@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL +81-88-880-2370
Homepage URL http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
Email tsutomun@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization Kochi Medical School
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 01 Day
Last modified on
2017 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032066

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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