UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Serum IL-6 levels on on postoperative 3.

Key secondary outcomes

Morbidities including surgical Site Infection, mortality, hospitalization days, IL-6 at postoperative day 1, and CRP at postoperative day 3.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Kazuhiro
Middle name
Last name	Hanazaki

Organization

Kochi Medical School Hospital

Division name

Director

Zip code

8505

Address

Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan

TEL

+81-88-880-2370

Email

tsutomun@kochi-u.ac.jp

Name of contact person

1st name	Tsutomu
Middle name
Last name	Namikawa

Organization

Kochi Medical School

Division name

Department of Surgery

Zip code

783-8505

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

Institute

Kochi Medical School

Institute

Department

Personal name

Organization

Kochi Medical School

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Board of Kochi Medical School

Address

Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan

Tel

088-880-2180

Email

is21@kochi-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

128

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

06

Month

23

Day

Date of IRB

2017

Year

06

Month

22

Day

Anticipated trial start date

2017

Year

07

Month

10

Day

Last follow-up date

2023

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

01

Day

Last modified on

2023

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032066